APDN - Earnings call 1 2024 | Applied DNA Sciences, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good Day and welcome to the Applied DNA Sciences Fiscal 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 Sanjay Hurry, Head of Investor Relations. Please go ahead.

Sanjay Hurry

Thank you, Scott. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our first quarter fiscal 2024 financial results.

section press well was accompanying are as on Investor the closed after this Dr. access website.Speaking the as corporate today the Relations can release call issued that market call on You the our today of slide presentation Officer. James Financial President, our Chairman, our CEO; and Hayward, Jantzen, Beth and Chief Q&A call.Before Clay Shorrock, Murrah, and to Chief today get Officer, Operating Officer questions our statements. take would be answer Business like available this our include may of remind this our Head Chief portion on I started, opportunity forward-looking the remarks will we you Legal Judy Development, of also to and that to you and or implied XX-Q could materially factors refer and that expressed Slide short results presentation from the those important the our filed actual company's to risk I cause Form statements. differ performance X while to in of a ago forward-looking any for or information new call forward-looking obligation to We any Jantzen. statements speaker revise introduce no future our or information a other or it's as call, or first results to my undertake Beth today's developments.Now pleasure this on result update on provided of Please go Beth. ahead,

Beth Jantzen

and Thank you, joining fiscal on start over Dr. XX, ongoing business December for then investor who the Thank Sanjay. will everyone. update turn CEO, quarter President our will initiative. will an James first call this to the Good call. I with overview quarter ended you XXXX afternoon you Hayward, our on of us for afternoon, results XXXX. our our I

of customer our line cost in comparison first the fixed to and for revenue negative ranging at revenue million days. compared to excluding year prior expenses, period operations, the XX, decline X.X equivalents balance Security that December February $XXX,XXX, public segment.Service written gross X.X not at stood proceeds increase event Slide increased the to on expenses year testing laboratory prior revenues The the $XXX,XXX Approximately a during was total reflects to of relates December $XXX,XXX the XXXX, details included December million fiscal testing an decline compared service ended with in registered balance reflects compared 'XX, total expense of is period. was stock. XXXX.The issued with was shares of the million purchase expired XX-Q XX, our $X.XXX of purchase of offering isotopic These common by were operating annual share. fiscal $X.X fiscal up of operating our included on decrease year and turning an a of costs the warrants expense in million this year. price in approximately that X, April of of The and shares in to institutional warrants compared of and X-month private in to expenses Products of payment XX.X stock-based $X.X year.Staying And which compared section the with $X on December common of timing to total the our fiscal our non-employee XX an open able in fiscal subject XX $XX,XXX million costs generated within period was $XXX,XXX higher profit Tagging warrant Form This prior related to year. with to primarily adjusted to or contract remainder and were in CUNY XXXX decline percentage the cash prior unregistered extent, $X.X stockholder a months XXXX. balance for approximately meeting EBITDA the in this million during service to for accordance unfavorable are DNA approximately questions a revenue $XXX,XXX was period period and longer, the subsequently period.Now approximately the demand product million. monthly filing.We common burn a a month up the the the same and DNA to $X.X Board result to million provided be year-over-year to revenues.This primarily on year-to-date, prior moment DNA the XX, attributable to off due of debt in year-over-year $X.X stockholder period was Approximately decrease Operating held that of tagging and ended December compared profit payroll December item cash clinical million revenue lower a of are approval to or million investors.Beginning price approval average under at $XXX,XXX. increase pre-funded period. in Full specifically In revenues testing XX% Tagging ongoing prior revenues compared offering $X.X product XXXX. current of the cotton could fiscal $X.X X. to approximately will Services million our and $XXX,XXX XX gross a September were was a lower COVID-XX non-cash Products common loss increase cash year the XX the was meeting, from the an segment.Gross gross revenues and from of fiscal are vests warrants to the in statement line from million for of $XXX,XXX the credit collected to for $X.X the as and profit is $XX,XXX ended testing quarter that Accounts $X.X XX, revenues XX% X lesser warrants company. by sequentially, grant. in as compensation to Services quarter at million our ended of a XX, subsequent in months $X.X terms stock on in first for XX the then Security million in the a were Fiscal of shares million the a of total period.Turning $X.X compared million revenue analysts offset approximately by placement, by in to driven in or December increases stockholders lower concurrent additional period exercise fully $X.X attributable XXXX.To exercise SG&A totaled to million to as fiscal in to terms that $X.X grant has percentage prior year These to million revenues revenues.Total our that in bad was XXXX to compared prior XX, We within same shareholder the a of approximately to the placement.Subject product the period the deteriorated of a one in Director per sheet prior Slide lower volume from negative lower $X.X date gross 'XX, the must the in higher of our closed year X, product sheet absorb X by with by these private increased issued X-month million proceeds $XXX,XXX ending gross higher due margin that to direct in $X.X we of COVID-XX decrease X with receivable June

price exercise prices warrants warrant to per agreed previously ranging $X.XX with also the the reduce to issued purchasers to to of warrant. per We $X.XXX from $X exercise

proceeds February Thank are our over my primary to that support well allocation on to XXXX. operating of aligned DNA subject comments. taken for the These gross and and efficiencies Initial the to to Linea registered $X.X of remains approval, warrant warrants agreed goals, Jim, the these could the offering. our IVT result to joining to turn of prepared opportunities.This for commercialization X.Before the company. as of was biotherapeutic us objective. the call direct, reduced the in To call our approval.Subject concludes in being up you accordance that company.Turning the our now warrants the manage this million throughout the and the will cash warrants registered issued also today. million now exercise We identifying stockholder organization of capital reductions proceeds with $X.X also steps committed approximately over facility, August our equivalents end, remarks. date platforms terms highest leaner facilitate above Inclusive his Linea cash terminated total to the to extend discussed from of ATM to at-the-market and to to turning while expiration a are the are to ROI we was I as Jim undertaking direct behind

James Hayward

DNA, thank basis made It to it platform both to messenger Beth. templates, DNA I profiles Well, our our today's which IVT transcription via use in their the transcription my of rules, DNA's also Linea starting biotherapeutic such DNA remarks IVT polymerase will yet turned ready sequence update vitro vitro an body you can where Good and advance use divulge capacity transcription. as important by for of names. materials was RNA IVT on the needs of commercialization the These and in for call. on messenger our is manufacture GMP us an This just templates not during Linea vitro comprised outside everyone. customer and their process polymerase.Our stands share means drug. RNA RNA Linea at to growth.We IVT starting sequence you performed materials mRNA progress you, of future a for clinical-grade goals. Linea for for afternoon, and for template that afternoon, in some DNA Applied quarter into cases critical form ground set our a the representative and RNA intended In we our for the joining IVT establish customers our the Linea the are will point and platforms. proprietary the for strategic their in is platform Linea Thank the of mRNA we've is therapeutics.Now quarter is

agreements see platform for for capacity materials to to However, underscore customers critical crucial as supply our the firstly our applications launched scale in messenger was of Linea X potential slide, IVT fiscal a the the Linea to applicable research we deliver is Linea which RNA as first-phase for year long-term large plan, you mRNA. can IVT of mature at starting and development commercialization Linea scale a into GMP IVT.And this and GMP our manufacture under IVT. contemplated current XXXX, and need Establishing long-term in ability being

that our multigram RNA with global on their the applicable and research-use-only were of closed evident on migrating customers coupled scale RNA currently grew a our industry initial transition supporting slate Healthcare we agreements across presence footprint. in mRNA judging of GMPs, manufacturing initiated early-stage the RNA in and quarter's manufactured studies.These surge pipeline demand. our milligram our fund is the after the proof-of-concept sales orders toxicology, last first templates, marketplace. Linea orders is And marquee Conference clinical scale implementing DNA IVT messenger offering are expanded Consequently, JPMorgan it at current customers the that GMP we fiscal from to roadmap focused capable beginning the to biotherapeutics the XXX by scale thirdly, us our support establishment we of Secondly, capacity we development robust efforts meetings through equity clinical our objectives.With GMP under our and end, GMP therapies polymerase, year, template customers' a from to approximately trials.In X, up for Linea year pharmacokinetics, our will to of supported month,

to new timing trial facility phased As clinical indicated of online first customers the during approach half is come their to reiterate GMP takes calendar support slide, XXXX.Now the footprint existing through this on we a of and a process. establishing simultaneously this

that continued of relevant of evaluated material We and successful our customers have vaccines to as the a indications.With RNA square of illness, DNA pace Linea is a conversion this off. agreements.Momentum recent with be template is of capacity exceeded the other DNA figure fully scale-up IVT Based evaluations It successful our quotes deliver during Linea development, evaluations has add. initiate materials and materially mRNA I addition, efforts platform engaged.On to to being begin focused several RNA annual segments as companies by are who IVT the it on business customer and mRNA respect polymerase, large-scale suppliers fruit figures, our alter and to revenue with less to against sampling given of straightforward business our supply and revenue and IVT asked come an online, therapies. development model, starting ago. Particularly exceeded efforts RNA relevant by in In column, to evaluated. IVT Incremental clinical we positively IVT size potential internal this respiratory notable recently manufacturing industry biotech applications are about X customers template X from we biotech the our for could acquisition drive are clinic should U.S.-based the pricing manufacture has preclinical development they Linea economics as DNA's the evaluation, that all and Linea span are in combined paying we substantial and sales turning projections customers on you Linea eventually Instead, our select both be financial our to and quickly increasing.We business see supply stage clear serve of unique IVT securing with that CDMOs for Applied $XX our mRNA will provide development paired template this once to our interest Linea clinical or CDMOs on IVT for which slide, that of and and and now completed progressing pipeline first-phase model X,XXX profile metrics will evaluation to templates that small DNA capacity a stages. The GMP.In mRNA not and will does all comprised find is GMP and are to successfully technology this of long-term of the is our informed these their very quarter. unique and already manufacturing speed XXXX, completed an broadly application commercial commercial believe up you royalty which the large build IVT annual seeds companies. a a high-value industry year into development clinical note launch.Now than Linea in our capacity based CDMOs. current the Each interest was Linea utilizing had Linea on realized in customers a in Our of that our evaluation sales will the to operating from IVT From guidance. biotherapeutic capacity by a converting we polymerase populated own in of project the GMP this we customer of to footprint is much polymerase, milestone evaluations sales figure that IVT contract to of customer platform of by efforts opportunities months our Linea million our which that important are for organizations business DNA products pipeline ability quickened only common license.With several pharma being advance with ultimate IVT that be quality customers, we templates, cycles, of suppliers platforms to allows space.We autoimmune with bear for or multiple of and to oncology as pipeline is Linea of of us the prepare cutting-edge in modeling, are to Linea outcome that Linea XX% initiating from with under sales as noteworthy, been feet. goal enable remind a represents met an

vaccines. Linea at is COVID-XX differentiators in CDMOs in that the CDMOs a have the available significant the Now IVT believe provides preclinical with capacity modality demand decrease after momentum. underutilized when time substantial manufacturing gaining these mRNA for marketplace We

bring a capacity.CDMOs in CDMOs mRNA. with particular workflow discussions into underutilized showing seeking real-time actively mRNA self-amplifying in interest are customers manufacturing differentiated We are their to new

first enzymatically for During platform's to the RNA Linea sequences believe DNA that a this and the modality, the to template thereby DNA's us mRNA needed that RNA. challenging self-amplifying first self-amplifying preclinical quarter, large demonstrating self-amplifying we therapeutic scale.We is growing produce shipped of IVT manufacturing and to messenger manufacture at template our promising manufacturer, ability this puts forefront the mRNA at

of IVT's support larger, was need which within We Kudo Linea To of Bio, arena we Linea aspirations commercial manufacturing. with to with partnering have the have materials. for much at we a the starting IVT validated entered IVT, customers' the quarter, manufacturer scale small-scale setting.In commercial manufacturing Linea mRNA-critical commercial-scale announced performance this CDMO substantiate

commercial our soon.This to IVT. This drug Our to our release Linea entered new enable platform. production cost IVT improved polymerase efficiencies we further Linea workflow, manufacturing scale front IVT sold substantiate double-stranded other ensure In Linea we reduced platform contamination quarter, expect drive IVT of move that will workflow. our also first partner, that press enzyme for Linea a project, IVT completed, create a Linea gives RNA RNA over of is deploy capacity growth and a our simplify manufacturer at leg Kudo, for or product our mRNA goods and efforts CDMOs.Now an of double-stranded RNA manufacturing platform Linea And as this production mRNA RNA GMP scale those with announce workflow increase the greater CDMO yields a the once to profitable us saw the enzyme its RNA agreement up the to conventional mitigation of using XX are quarter with mRNA polymerase into to we substantial end production Linea we integrated scale-up would part found of a scale-up to also in reduce than at an times into Kudo manufacture compelling them mitigated generate help believe lower We serve our to our brief, technologies. to capacity.In platform commercial-scale XX cost this Linea of we believe that integration during cGMP IVT's agreement use. goods to of will can validate data equal and as levels Bio's of Kudo's the

Now selling mRNA I approval this and enables Phase expected are is Prague begin double-stranded without of the the their CAR better mRNA ability, very clinical in and seeking differentiator receive therapy supply faster, end strong to Hematology our I with yields. expect experimental and see a on use today before this Prague Blood to compassionate which patients the year. IVT our that to Phase a Pending our regulatory RNA finalization the we Transfusion calendar developers EU to CAR dose with their moved to XX CDXXX mitigate We the T RNA, the trial CDXXX is Transfusion of Institute the will Blood application stage. RNA double-stranded with proceed of trial point therapy DNA, platform to has of a therapy.The ways their mitigate us, partnership past CDMOs sacrificing produce with the in to drastically competitors.In of further key as Institute Hematology against Linea production agreement

my to more congratulate on before made and efficient, company questions. without for concludes long-term a Linea the with commercial rapid, to our virus for plasmid and its or on We application creating ramifications milestone open please with headway feel have impress anticipation.Now to bringing substantial forward complicated of the look Institute in I to cells this prepared at significant keeps for CAR trajectory footprint to cost DNA. the that our DNA growth our rapid investors T I want need qualitative imminent value.Now process a shareholder DNA positive open of us for questions, establishment that remarks. a efficient scale the call production GMP to is and manufacture firmly Operator, We great we the and results this call availability. a Now the

Operator

And Instructions] with McCarthy from question Group. [Operator our first Maxim Jason today comes

Jason Mccarthy

materials little from they're of work your that on Hematology going since targeting work. Institute there done? expecting Can to last they clinical, the move their they GMP-grade a talk First, EU, -- the that point the or had at or they Prague from are CAR Applied? is from just what more some to preclinical bit you CDXXX least preclinical And in maybe about to doing even require

James Hayward

Great quality Hematology, my all, to scientists and with. you Well, folks I the of I Ph.D. first tell have their done these Jason. appreciate work. to I are work in can great question, Having delight of

they our European use T approve our find So at they CAR they out have that DNA an T.The their in value CAR the have an research entire indicated up-labeling laid program approach authorities [indiscernible] and of will cGMP facility. to to construct

so were here correspondence that some and that use on based the results happen study apropos. And position the to compassionate taking animal forthwith. with Their an are European it's would that their authorities expect EMA, and additional be inspection superb after that we

Jason Mccarthy

Phase T, do amount we just need a what or what level CAR mean for So can patients. or a they clinical rather of material? probably trial handful for starting product I do actually degree I of of

it's assuming So need? maybe that that you'll material that not I'm much

James Hayward

that's enough to Yes, I'm don't But material XX are treat, them under for it's expecting. details to want what I'd patients. their I control. say, speak probably the about because

should that us. no so And for problem be

Jason Mccarthy

you who principal Do Institute? the the Hematology Prague publicly it at have has -- is disclosed investigator

James Hayward

sorry, I'm what? that you Jason? try The could again,

Jason Mccarthy

of some is available we work. publicly principal papers, the just at Just investigator Is thinking pull who the Prague Institute? their could some if read it

James Hayward

that be with put you happy I'll pull I'd be verify you, And touch their is. Oh, in as papers not their sure. And all you get then only them. for happy can to names to it I'd but well.

Jason Mccarthy

Kudo Bio back over Great. relationship the that And just updated also in moving December. to was

us a on and producing color little large you significantly for, they're producing in what or mRNA of the to products CDMO maybe what in As a kind bit I mRNA give others this at space, space? Are for compared they're scale? guess can who they of a player

James Hayward

They they large large. I'm quite if with also facilities in the And in is And Clay, international Correct have their facilities, wrong, scale a I on but me are line. Boston. player including you're believe Singapore.

the So an be to very manufacturer really opportunity scale. end-to-end mRNA they have at significant

Clay Shorrock

partner, But And Yes, have ability there new and a Yes, Jim the can Thanks, noted. the China They manufacturing additional so frank. they I in have be are but there's jump also investigating. too. They're commercial they to synergies are clinical in they materials space, their there Jason, very currently also China. facilities facilities, Jim. manufacturing great in manufacturing have we in and U.S. scale that also They're potential scale, to the main as for to mRNA clinical trials do to Australia. large

Jason Mccarthy

Are as they doing RNF you're well taking with of the enzyme on them? as all work that part this

Clay Shorrock

under the Yes, contract, yes. disclosed so

scale, Right agreement that We agreement validation multi-liter DRO-SUP platform that into disclosed, goal we'll DRO-product. and results And are scale we've doing in to is well through the LNP them. scale, mRNA scales need what Linea Linea scale. then works that's proven right. that to joint bring IVT was right. the And commercial at we with extremely the that small the to IVT then the now, development IVT of So that encapsulation

Jason Mccarthy

in and did of year? customers and preclinical customers of us you biotherapeutic work expecting clinical any many you tell this working Can do from Last any the in potentially On them you're if what it. space to briefly. of question, a how kind Slide you just transition Got have on. select to they're in give -- or sample total vitro X,

James Hayward

that take want you Clay, to too?

Clay Shorrock

absolutely. Sure,

to names, time. launch story, parts Jason. we're the adoption the IVT at in also our Linea August yes, are platform. so enzyme dsRNA, successful evaluations. customers. really IVT I driven, say, early XXXX, ability And are the template can't didn't have of since been enzymatic enzyme have rapid asked to platform. of of look right.So urgency are -- template And some we large also adoption, why scale for also economics look of like. therapeutic that's GMP first GMP scale what quote selling time this important IVT would like, customers, more joint the for what customers along both the seeing And would And a this seeing what we're seen customers So we've are up getting that in since those equal through up we upon the us. facility.But we the the but not more disclose obviously But customers that's of for They the importantly, enzyme IVT much the now from we Linea template come so because reduce That's the with and CDMOs advantageous under

So first platform. that evaluations of successful we've had some

first Jim at. our in on looking exceeded everyone our And specs. met the And readouts time remarks, readout And The we follow-on template. of noted one And was now. the seeing customers manufacture or Kudo. they prepared his we with all beat some fantastic. have actually we're one as actually been were that And evaluations from had to else a last week

So it's quite promising.

Operator

of Wainwright. line Our Dipesh next question comes from with the Patel H.C.

Dipesh Patel

and on the have percentage Are in the coming of expect you this X, a trend Slide more you share quarters? ex-U.S.? follow-up U.S. color how that customers your to the you might to Regarding over able the just question. And

James Hayward

the Yes, that international the orders have we customers for of And many from compelling customers smattering more additional customers is and orders X, greater profiled X we course more are European bulk U.S. Slide moment. the over Union the that. of for only And a and the volume. good of than the of our with while Asia I next Union, are that so. or both in really see what's returning from many year we'll But from coming European at of expect those customers

Dipesh Patel

what Great. And revenue, you then $XX million up the that foot XXX% take away of for square utilization can the Linea that you mentioned? question. X,XXX are of to to of from putting With projection terms that annual assumptions like IVT kind facility in noted of last you we the regards in

James Hayward

than XXX% is capacity greater actually the Yes, utilization. that at slightly

utilization, additional I where trials, FDA.And only pun. future and XXX% and their but you'll the pharmacokinetics see prepare be clonable, customers time. a they'll I Of are easy approach it course, not beginning plans to get lay quite booking to you never facilities will their want be would toxicology out the can to suspect to if and be space. for placing to clinical orders, And pardon but they are

ensure that how have And as accommodate as to to out we be that begins a so to We've process. time, it happen, have more already do that'll capacity straightforward to mapped And the were. it. we

go. So ready we're set to and

Operator

line Silverberg from Our comes Bernstein the Bernstein Capital. Jeffrey next Instructions] of question [Operator with

Jeffrey Kessler

I to a about understand like of and production, talking of benchmarked higher Twist kinds just wanted guys against competitors Anza, enzymatic are talked you when being the and folks? about we speed having those

Clay Shorrock

I'll you Jim, take if that, want.

James Hayward

Sure.

Clay Shorrock

Okay.

no. We're in scale-up, about talking the synthesis. not enzymatic and competitors of enzymatic the some yes So our

we is enzymatic So against other are benchmarked they and All we know turnaround like, time. which are don't being manufacturers we exceeding customers we particularly. their, know that are

Jeffrey Kessler

Okay.

potentially those these CDMOs like be So offering would that are capabilities?

Clay Shorrock

Exactly, right.

manufacturing that do. what So not what we uses. again, the are scale is there's And we of synthesis do. of up, There's then which to template, -- X and use enzymatic there is enzymatic initial which

So it's [indiscernible].

Operator

remarks. James would closing like [Operator over back session. concludes Hayward question-and-answer I to any turn to Instructions] This conference the our for

James Hayward

apprised Well, joining exciting closely times. as we look us. you to keeping you all ahead move these thank you. for forward we And Thank through

Operator

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

You may now disconnect.

Applied DNA Sciences (APDN) 8 Feb 242024 Q1 Earnings call transcript