APDN - Earnings call transcript Q1 2025 | Applied DNA Sciences, Inc.

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Operator

Good day, and welcome to the Applied DNA Sciences First Quarter Fiscal 2025 Financial Results. [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

David. you, Thank opportunities. welcome XXXX and discuss Applied First and DNA's financial Good Results to Conference Fiscal growth progress business Financial operational will Call, Quarter and afternoon, performance, the where our we

Chairman subsidiary. Joining me on Financial Beth Judy newly call Officer today Officer; President; President and our appointed our our our appointed and Chief and Hayward, recently Legal are Murrah, Jantzen, CEO; James the our LineaRx Chief Clay of Shorrock, the

open the and will to questions Following analysts we management's line from our institutional remarks, investors.

today, this the was website. You corporate well may call will section release accompanying Investor press slide IR access the also the website. this of of our of A the be the archived replay issued Relations that after call section on of market closed the on as presentation portion as audio

to provided results or statements a from to get differ obligation or any Slide the information or expressed in before revise you result forward-looking on or forward-looking me Before factors to information you that we cause this and the for that Form important could remarks new risk actual statements. call XX-Q undertake this or of no remind statements. those today other any forward-looking We results developments. our performance starting started, implied may include materially presentation and X update opportunity refer to as our company's let -- of I take future

introduce Jantzen. go Please Now our speaker Beth call, ahead, it's first my pleasure on to today's Beth.

Beth Jantzen

good and everyone. Sanjay, you, afternoon, Thank

of high-level provide call our today. overview me will let First, for agenda of finances the company. the a the set I

provide year Clay finally, on Judy through the briefly milestones our update our will and achieved operations. will its will during walk And XXXX. fiscal update important you provide an strategy. business LRx Next, with on growth you Then an Jim

and the the context, into our cash to initiative Prefacing undertaken quarter the to the structure. first bolster a of strategy strategic via Having and my burn optimize our this put reserves necessary belief strategy financial manufacturing our 'XX, in subsidiary. groundwork our of sustainable initiated its to quarter, restructuring of This to necessary the lead create restructuring during fiscal rate our our for LineaRx synthetic growth our support review value much our performance that we cash potential reflects greatest and cost reduce support DNA offers shareholders. intended to results for LineaRx was our the

a fiscal quarterly XXXX Clay LineaRx press and and October and the DNA on be in XXXX, Our the execution of business facility We SiteOne release we Products their anticipate point from this point last the elaborate of reinforced will remarks. segment. to support our results With [ in Security are financing today, a certification the end exit be tagging Jim expect year the current ] which with during our what down wind to announcing GMP our of by we quarter. Services completed month

primarily related of implemented workforce total count this XX% we result, a reduction employees to of As head a in approximately segment.

in of incur will action. the approximately a onetime this March $XXX,XXX charge to related ending We XX quarter

of first $XXX,XXX for with results for with beginning same compared fiscal fiscal first revenues our and million the quarter of $X.X operations. to our statement 'XX. were Total for Turning quarter 'XX the the financial period of

DNA of and was services textile from our higher business product our in tagging an from increase isotopic year-over-year revenue. result a revenue The testing segment increase

the primarily lower to compensation $X with DNA the quarter stock-based the in for decrease in consulting selling, European attributable a operating a first the from lower our $X.X million to improvement a related was loss year-over-year general Our lesser million of year period. operating is expenses prior subsidiary. in compared resulting from This costs loss administrative expense, closure and and, tagging extent, segment's to

for quarter $X.X liability, I change remind the year $X.X in loss in warrants million our as shareholders value period. first that price. has on unrealized prior of classified the relationship Net compared the includes fair which an with a million the an inverse was gain stock loss our net with

For loss negative we million quarter prior operations. $X.X year negative operating the for in to highlight million a Adjusted improved with the period. the representing as this a EBITDA reason, best $X.X company's first compared

on million exercises our our proceeds on of $X.X from Now which Cash of net 'XX. and Series XX, turning A to December offering This compares cash XX to warrant $X.X balance $XX,XXX. million includes equivalents cash equivalents and sheet. balance million September of October cash approximately totaled and $X.X

As XX, of December stood $XXX,XXX. at receivable approximately our account

is over cash flat the just and million in same the average monthly with year. $X.X essentially prior year-to-date fiscal burn Our period

burn fourth average Our the monthly was cash of fiscal XXXX $X.X for quarter million.

on XX, cash exercises Series equivalents 'XX, was figure approximately totaling $XXX,XXX. January Cash This and A warrant includes $X.X million. additional

a a of doubt maintains of going from prior our XX-Q substantial Form filed just Our disclosure concern. XX-K a

alleviate adjourned lack to on concern to in warrants the and We special the quorum. our in October January the issued raise revenues approval plan financing further or our exercisability ability Our a sought ability due on of is XXXX generate capital. that meeting to going shareholder XX business dependent of a implement was for the

date on have a.m. own the the shares as Eastern encourage shareholders to. all Time, their will XX, yet November shares We the not who XX:XX proposal meeting and XXXX, voted tomorrow reconvene of record of at we who

XX% voted January XX the were shares favor in meeting, all As of proposal. of the that so did of

the will call This Jim you to concludes us his Thank for now Jim? today. comments. remarks. my prepared over I for turn joining

James Hayward

on ability scale good a call. to our through the And plasmid begin reflects subsidiary The shareholder joining demand addressing today's you enzematically trends want deeper to has focus all meet to financial commitment by and structure, restructuring an therapeutics to us its for prudent Thank management, LineaRx. community rebuilding strategic our cost for DNA our chiefly in restructuring. everyone. alternatives and the afternoon, I and at pandemic, interest DNA. Post on full on growing investor bio among emerging produce centered optimized Beth. LineaRx to you, value Thank

XX months, business and We customers blur and In The we've cumulatively tagging DNA to DNA our time. the are been LineaRx's And offer. Segment our while and informed our we'll their about particular, have supported optimistic Linea operational reduction. drove is our segments market Linea return exceeded call, exit our talk we expectations. of this now the own of progress. in most an will acceleration IVT interest for we even profitability. pace in disparate to ready and the have to our workforce platforms feedback of but seen a on them each on decision biotherapeutics ROIs recognize last have these ready what This certain deliver. offer as investment, that to of implement for business be segment path period on

not then significant a XXXX. during Fiscal will did have benefit We and Clay certain address quarter let XXXX milestones the Therefore, we our fourth the successes. investor achieved call. had strategy summarize fiscal I year, of key me for

internally our with So CDMO Linea in fiscal conclusive. we the were XXXX, partner IVT and platform. Data validated generated

myeloid to reduction a for legacy commercial a clinic. in that therapy in of Our or IHBT of on the problematic neutral And Linea its contamination enable of RNA cost We the is trial. scale. and platform T trial I Prague entered leukemia. DNA Phase critical as for component first-in-human DNA manufacturable received and acute utilizes therapy. double-stranded a blood Institute announced, approval treatment CAR also Hematology CAR vector manufacturing and/or free demonstrates platforms. a Linea transfusion refractory a T relapsed To workflow rapidly IHBT's clinical of initiated viral the a

approval customer rate expectations. in clinical fiscal the has of exceeded our LineaRx's of This In Furthermore, GMP the XXXX, DNA's in XX setting, over and as we Linea engaged acquisition instance expect certification, a multiple projects us key we regulatory validated our to a milestone. a multiple customer in GMP highlights first customers XXXX. consent use advance projects, calendar supplier. clinic enter of

to Board our strategic quality of drive will business restructuring, where toward the oversee operational a all she promoted across our Judy and segments. Murrah President part excellence As continued

a to Clay. In Shorrock. Judy the greater moment, given Similarly, responsibility the will additional in discuss role Clay Board has of Congratulations, LineaRx of Judy. Congratulations, her detail. precedent

assay. his a Clay has for PGx And licensed list out for recent our led New secured LineaRx we to TRX all PGx, key use ] now cultivated basis our our State we years, XX approval DNA pharmacogenomics Health officer global business York assay and in that testing mark strategy and in for of service. are has forms Department samples an addition MVX sales In states. [ LDT expansion from duties accept to Clinical of corporate secured the for And customers. Applied

With this agreements. approach DNA we've scale, entry site as low GMP Finally, empowering an space operational a ISO- long-term with at workspaces. was X to last certified ISO-X supply GMP our into CapEx demonstrated enzymatic production our month, site,

to turn me LineaRx's specific the to insights into some let plans fiscal Clay? XXXX. Now for over call offer Clay

Clay Shorrock

Well, thank you, Jim.

to want inflection thank an management DNA trajectory. opportunity believe point of Directors Board I for LineaRx lead its the approach as we Applied to team I and the is First, what in

DNA. sitting place, you be years I we legal and roles. of story, and since have companies. intellectual a and and engine business in building those will plan a My is for For business And are who was background property the various biology for our I growth Applied I in I have DNA new XXXX, passion Applied XX experience. with of legal in believe have LineaRx to

has pandemic, COVID-XX enzymatically trajectory the DNA the rapidly for growth produced with Now increased.

Linea With market site this our with fiscal As we are demand strong in online, see over a initial projects active you and monetizing platforms. on Linea focused XXXX,-- IVT XX GMP for demand. our mentioned, now DNA we

templates. is capacity this end, our emphasis for So IVT sell commercial our to first, GMP threefold: to

capabilities develop derisk to leverage scalability and nil platform Second, to breakeven. growth products LineaRx additional third, our CapEx and with to reach and

in ready It's from IVT material as opportunity believe starting quick made pipelines. our that each new almost therapies facility. market materials at GMP are or to a the IVT We mRNA to our in an IVT manufacturing is produce So The DNA first, represent therapies transcription, facility. of these grow template. a templates mRNA global vitro with to GMP these template continues XXX produce we a in finer, called

we a for order $XXX,XXX to Based used platform. $X customer the Linea from clinical phases about IVT million the production in robust this currently in as We're sales templates LineaRx the clinical about exciting pipeline and IVT the templates. the templates backdrop anticipate development potential initial eventually revenue ranges for supply. on It of with manufacturing RNA customer GMP opportunity for therapeutics $XX,XXX the GMP our If into frame. with sold we XXXX time varies. per is that entered through Phase for stages commercial IVT completed, of for progress the opportunity trial it materials, for in developer GMV rapidly It's June IVT mRNA the May, final opportunities million current project a for These projects a opportunity I templates grow against Linea successfully IVT the supply. development for corresponding in under $X alone, interactions, Boston-based

addition, manufacturing To GMP several that we closing during contracts hire new have funnel, successful physician months. Vice therapeutic the have key to clinic evaluations multiperson work our seek We our the organization restructuring, the This and of led to are leader. developers these expand technology opinion quarter. employee to the within we on of industry we sales with targeting undergone for staff end XX LineaRx. level, In help by and further which sales current continue CDMOs by a in President will next created team plan be a our an

we trade and overhauling have of materials. process the LineaRx addition, shows are at attendance In the increased website our and marketing in

late manufacturing Linea a buffer in proprietary are of the increase of new wheels development and fidelity enzyme enzyme DNA. to of we tenant the Finally, sequence stages and and system are

we potentially as through technology, goods DNA addition profile cost to provide this launched, improve higher once enzyme yields. producers will new gain believe of margin while sales advantage our us the a with tool of same our being In valuable and distinct a time, enzymatic lower a at proprietary

does rarely a that single Now successful business, make and for history us different. we're no product a shows

developed we business. be to such, have LRx multiproduct as So a

use support initial forms several editing high the While are IVT announcing Linea to non-IT plasmid, additional form used gene ended Linea of DNA Linea type enzymatic new has the that a XXXX optimized wide the and or homology believe segments, template new the HDR are DNA, DNA a and applications. of modalities. we GMP templates gene-editing DNA donor we for a -- the of we today for we primed built believe to donor development in donor focus of Linea Linea which engaged in a CRISPR-mediated in calendar DNA Linea fidelity call been -- double-stranded availability in growth commonly DNA diverse a numerous over availability DNA donor as is direct CRISPR alternative. with targeted currently [indiscernible] We LRx DNA. of revenue range our of Due base IVT, repair life is has DNA donor applications, for produced large-scale use a are now advantages available donor enzymatically later only in year. is the cell-free this in market research for use fiscal

actively are for product. drug substance and allow of addition, the upgrading our linear In to DNA capabilities GMP we manufacturer drug

personalized to of vaccines. of clinical plenty be applications, allow high-value ranging angi will upgrades These to CAR wide a in manufacturing range medicine, from DNA DNA T used

to Turning strategy. our finally growth

is operational. our now and to Our proven facility ability scale GMP manufacture is initial to

sharpening using We are growth and to profitability. focus achieve platform's requirements our our invested now CapEx on low

GMP to DNA opposed large instruments minimal DNA require environmentally and flatmed-based space the controlled that with uses platform instrumentation As expensive benchtop manufacturing requirements. spaces linear

than Our square GMP designs room space. feet how controlled use of designed in manufacturing less facility X,XXX initial was an and modular clean end-to-end workflow environmentally to

instrumentation are in manufacture And smaller volumes DNA plasma our and expensive. in is we less since cost purification estimates Our benchtop effective. smaller

be PCR contaminants QC approach to which lower required copy workflows, of potential scale manufacturing of for legacy enable rapidly unique fewer in addition, implied X GMP for CapEx This technologies. will platform our DNA has a materials manufacturing our ability results with leads incoming the DNA to that and bachelors our paste near-term benefits. costs. fraction these simple and a using believe We attributes In raw and

small are rooms, our via our CapEx on time deal production mimic and other First, capacity clean contracts using our the complex facility because our large construction capital-intensive to risk. closely hopefully, before we commercial Don't build identical contracts and face and real reducing timing, signed. we scale come thereby can to align necessary build on we contract simple can additional copy-and-paste it's approach, sheet to will they it, of we can Instead, to manufacturing rapidly build modular with commercial where a spend CDMOs. balance

believe our $X construction achieve biologics opportunity with our modular than we into believe of target CDMOs. capacity the final that on significantly CapEx Second, the facility a of company, of each of to cost that We is for legacy in and instrumentation, we business and to has than the a holds. in our product. DNA This, of space. margin production to $XX needed look Based our launch each juncture less on million strong particularly been It to DNA markets has forward cleaning profitability million revenue profile future our coupled believe, expertise other investments a costs new on piece historically year multiyear current support necessary senior In conclusion, potential even $XX less our products this million. for production per depending investment a mix the we of applicable fraction commercialize PCRBs for break GMP higher to margin the allow our the the profile. biologics capital to strategy representing the required pivotal of operational the company is with technologies,

over to you. Judy, Now

Judith Murrah

speak afternoon, everyone. Thank and good It's my you to today. with you, pleasure Clay,

Jim, opportunity Board and focus From and comments, we thank on the with now company innovative objectives. be first are Applied to to charter our a this market of the clear stakeholders. and further use eager and operational key of excellence value its driving I of operations my our to unlock achieving centered expand and efforts all be my broader company, operations company. Jim's me should lead Directors now of DNA the President and the opportunity. for business I'm immediate My at will for Clay's occasion as highly ongoing setting in a the Let tremendous fellow sitting to precipice company's enabling officers overseeing continue that

opportunity new Also quality, success. top-notch allocation future product we deliberate resource orchestrate sales schedules will customer orchestrating determine in with of my volumes initiatives. well our the in and will These work towards much mix, How to team success. I role, delivery growth ensure closure,

drive the With in bench execution on how the maintain GMP same deep and quality discipline a forward. delivered. we we and culture. at time, spending have While And going a to manage cornerstone, we

demanding and direct We are our operated under a to bar with their not of XX-plus years, State New starting from the We've York health patients. XXXX FDA, operations and at scratch. in high care ISO scale Department managed for of contact Health, providers lab clinical and we've the

is GMP must individual, a also every function in every culture, pursuit quality that on this every experience, and predicated permeate our Leveraging a quality opportunity.

implemented largest continuing today North IVT resides medicine, regulatory have and do in miss to a GLP higher in have our for these for Authority adhere genetic building We Our They for and materials as place under budget. our offer level supply have to the grade body to IVD the FDA RUO manufacturing capacity DNA customer globally. manufacturing GMP-grade To schedules, European knowledge, no supplier America, large-scale of us PCR-produced base templates Medicine we This, and we today. mission-critical force the and addition market. blocks Asian in also supply requirements. and

actually annual have of grade. template We delivered have several product XX in Quantity over initial projected an IVT underly capacity grams. we GLP categories across

materials doses to product instruments, with our this stability and analytical For to operative from vaccines. of suite to million an incoming customers of for system capability mRNA of and context, up outbound all chambers XX offer produce complement our sufficient is grams customers manufacturing quality to capacity We programs XX product. full a

GMP been Applied has undertaking Clinical TRX testing lab. to of Labs admittedly face In state. PGx, at a managed service, the DNA our our that pharmacogenomics clinical been steady considerable the has Moving at

forward, further reimbursement markets Looking PGx, which for a are the assessing qualification and capabilities. to and are is very of insurance establish elements state more such evaluate laboratory York certified promising potentially value Under segments the in could we assays. for target our asset, our evaluation additional commodity. New our things that as rare validation diagnostic

our are closing, goals In significant.

structures the we out are this our managing remain prudent that is know to and in resources end, thereafter through we To capture financial allocations restructuring finite. market there. that and Our will

business that modify to to of dynamics. the We unlock closely operations change. business across the infrastructure, shareholders. and I the have to we tuned will believe may people our stay and aspects value strongly our to as Ready refine and context market all execute strategy for the determination company

Thank you, over back to now for the and I remarks. Jim will turn concluding call

James Hayward

Judith. you, Thank

the want some collective key The call questions, is reinforce Before receptive to opening to platforms. to from I market very our takeaways remarks. our

GNP further ranging deliver from one we SiteOne side clinical and RUO now evaluation in is a have expansion and we Our And demand. can product customer warranted by as blueprint to for of a grade. place,

And these the clinical excellent of graduate late into sizes development. an preclinical through customers of therapies convert phases will or have DNA to increase stable and their We recurring as those orders.

and targeting time a rebuilding all our growth that additional offering. your product path attention OpEx DNA new and bolstering combination are will production. disciplined We from come DNA afternoon. markets you to And, this Well, for through of thank enzymatic the we value and shareholder recognize

open please the call to Operator, questions.

Operator

H.C. question Wainwright. Chen from [Operator Yi Our with Instructions] comes first

Unknown Analyst

product. products even of IVT you the for Kind was CAR on Wainwright. to you CRISPR guys developing Yi I opportunity provide the therapies new from conventional interested that of there Linea the T Eduardo how for? could wondering therapies these you maybe or know existing quantify H.C. kind is color any versus This if are on the for

James Hayward

Clay, for you. that's

Clay Shorrock

Eduardo. sure Jim, at Sure absouletly. [indiscernible]

is IVT DNA we of and ] PCR the so good, ended blood think lot In [ ending a there's the yes, template donor market. between parallels that very So part, DNA.

at DNA. looked the saw market we opportunities so where market those large-scale blood ended and And for

DNA. One of other the HCR them in is is IVT template, our

to use manufacturing workflow to So workflow our our no existing modifications there. can donor meet that's the the logic We DNA.

kind the existing amplification an of of it's line. manufacturing So

in do in like In and the in ways move believe large base mRNA viral are terms that CAR it they're especially market, therapy space manufacturing vector is of start more But some very and gene CRISPR-based mature not. opportunity, kind some -- gene therapeutics a to editing versus we lentivirus cell the ossiCRISPR ways, market as to less of workflows. T the than

And that's excited something we're very about.

vivo T editing gene a We near has really [indiscernible]. like CAR term, focused we're kind on of also but think future, any in workflows those and

Unknown Analyst

if of or Great. any scaling That's were from And really get then new existing color increased -- were and increases where coming on primarily of hoping helpful. also customer I from, primarily kind kind they could if I revenue acquisitions the manufacturing of customers? was

Beth Jantzen

increases one the marking while. shipment customer The had So volume cotton. of in for the a primary reason X And revenue. testing bump our for came for was increased that from a business. DNA revenue came product for the tagging from other isotopic contracts this QX, we've services It's of quarter of our within

James Hayward

Clay, to add? you'd like is anything there

Clay Shorrock

are the is manufacture I with add to contract would to a restructuring. have retaining currently the LineaRx. [indiscernible] taggant of cotton for that same the workflows we that able a we shipment We're DNA to post customer

that I So that's does make have sense Jim, no, to contract. add. it to But keep

Unknown Analyst

you And then Phase should kind in for that I'm we the I revenue mentioned curious Great. kind and just what more human, I, could the that? you -- maybe expect know line that have time of line of mentioned therapy. line recognition I dynamics the I of first And in and AML -- one if think it's the time

Unknown Executive

time the The line Yes. it is trial, so in for Republic. that Czech

Phase I in cars. a months. probably make is about XX uses is T interesting that CAR nonviral system a transposon the It's to I an actually think therapy

able process in the twofold. how easily. the commercial terms because But we a part to it's hospital-based trial. going quite scale revenue it's know entity. large not by regulatory were They're excited was approval there We the So of that. we are for don't One, important opportunity, get to run through

also plasm would faster, the the process but two, customer. ease for competitor we chosen were a regulatory because we were over And

don't main it there's are those that. necessarily, I critically sell. was X know Europe. trial the revenue opportunity takeaways in the I of know but in large validation Jim, don't that a from So important

James Hayward

demonstrates it base, which, utilize of an to urgently in the many linear DNA is in that material required. CAR provide we a therapies. think adequate And path, T broader entire a the I cases, industry generation industry is faster to these

Operator

question-and-answer our would concludes session. remarks. This Hayward over I conference turn to like closing back any for Dr. the to

James Hayward

Well, thank for you, thank you. today's and the everyone, Operator, now on you us conclude joining call. can call.

Operator

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

may You now disconnect.

Applied DNA Sciences (APDN) 13 Feb 252025 Q1 Earnings call transcript