AXDX - Earnings call transcript Q4 2023 | Accelerate Diagnostics, Inc.

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Operator

Hello, and welcome to the Accelerate Diagnostics Fourth Quarter and Full Year 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to hand the call to Laura Pierson with Accelerate Diagnostics. Laura, please go ahead.

Laura Pierson

Before we begin, it is important to share that information presented during this call may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

statements facts. future projections, are those include historical not statements about and our that Forward-looking statements are factors forward-looking to our All that results risks, are conference actual uncertainties subject call and differ other to that cause made could materially. during this

in file discussed our in Jack It to my with for the detail Form XXXX and now annual December pleasure company's CEO, year SEC. Phillips. ended greater XX, on President introduce other XX-K are These report the reports and the we is

Jack Phillips

Thank will you, Today, and would near-term Laura. automated Good afternoon, I innovation milestones revolutionize like everyone. exciting the susceptibility with to testing. how program cover discuss Wave will Wave. I both

our Additionally, and partnership process FDA I on our will provide strategic submission. updates Arc

to results. First, I will pass it over our CFO, summarize to our David financial Patience,

David Patience

sales million the $X.X an and inventory XX% and $X by year. This the current year. the same million lower the year-to-date. prior was for period. Thank good approximately approximately to quarter increase million was driven in excess the quarter and decline $X Net This onetime approximately in for in XXXX. in third overall The $XX.X to during by Gross instrument decrease everyone. The afternoon, million of approximately sales were quarter partially resulted Jack, consumable and the was in a XX% the write-down sales. This primarily $XX.X net for offset sales net million in you, period approximately same for from compares and margin prior XX% compares period year-to-date. recurring the inventory margin gross of

primarily both $XX.X in for $X.X $X.X same million $X.X to compares and lower The as our lower million program expenses. were compares period were the the This and expenses million the resulted decline prior overall expenses and decline and to Research for employee-related employee-related lower and million to the $XX.X administrative and Selling, million quarter The This for for $X prior in for resulted expenses expenses million SG&A period third-party expenses to as expenses. in the $XX.X year. the due overall development in development well due R&D million year. year-to-date. same Wave $XX.X year-to-date. general million primarily quarter

reduced loss $X.XX Our in burn and the and the million quarter in for of million for for approximately net $XX cash the share quarter $XX.X resulting meaningfully million per the used Cash for of the and quarterly $XX.X quarter for net $X.X was million the our year, loss second a year. half the $X.XX We was year. for XXXX.

on reductions We are burn cash drive significant continuing moving focused to forward. further in

Jack, Wave. Now our to exciting back discuss to innovations you, with

Jack Phillips

David. Thanks,

focused an As a Wave by system and and These we the a trial delivering full several XX key we and on for preclinical development exit next include the positive submission menu. FDA months. phase, blood over culture followed trial clinical clearance milestones are gram-negative the

broth organisms, unique to run comparison. images were for XX reference These results platforms. approximately method XX,XXX X,XXX than more than taken were were in consumable approach Over our our very the significant Wave exited in set. have This progress Leveraging a formally extremely we included development with was thorough. experience the developing AST made and on XXX more million Wave XX,XXX several impressive the and which cards compared running is deep past months, microdilutions, data market,

resolve bug-drug for less to X.X imaging than extensive with holographic Wave's data, time possible to an to average unique makes is what the result Along combinations. deliver unprecedented is hours. strong time technology it

data. leveraging our and gram-negative the many growth coli, most E. For morphology for Wave can X.X on panel definitive make organism, calls prevalent hours under in by drugs

very major threat difficult let for to there which and While is microbiologists, Pseudomonas aeruginosa challenging it's is hospitalized many highlights, highlight of type because bacteria me treat are highly a resistant. other patients particularly one to

is grow hours optimal changes and traditional potential to make an to calls bacteria X meropenem. impact drug rapid slow-growing platforms. susceptibility within X.X and are same important make for hours Pseudomonas Often in must under in put ensuring significant hours for bacteria, morphology make This has this to in carbapenem able both Wave patients challenges over by capture definitive is X which many the an clinical the a therapy on presents accurate call. shift.

to begin completed With combinations, trial. most the are confidently on successfully Wave bug-drug our development we challenging preclinical ready

will challenge preclinical as sites, as contrived X enrolling well trial both fresh include Our isolates. perspective

time results. Our method and objective to performance reference is to demonstrate compared to verify the AST our

Additionally, run our cards within lab train successfully setting. a microbiology clinical and ability the to trial ship, and install, preclinical demonstrates Wave systems

Our first running samples. a and clinical in system is has microbiology lab been installed

schedule. will specimens communicated and include starting be the end trial trial X external the clinical in will preclinical in by second start April, X anticipate aligned of our site total coming sites wrapping trial We The a with patient confidence X sites quarter the plus weeks. preclinical of us We will a second additional up installing trial. in our sites, identified. giving the clinical running The previously already clinical the

clearance XX In deliver in through the assay. for the months, next our summary, the XXX(k) followed quarter anticipate by our to X, FDA should last months about We system by the on end by the we to quarter. thereafter submission X third mid-XXXX. to remain With we key milestones of and the track FDA of shortly XX trial over first be submission approved anticipate

at The isolated culture results, estimated is Wave for specimens uniquely can and disrupt and that on industry-leading $X Wave. colony surpassing both and market $XXX Turning microbiology same billion. cost time consolidated strategy with market, process platform brings systems. now PBC the to profitable the around million isolate positioned market providing approximately scalability, the at positive susceptibility PBC workflow a testing to throughput Accelerate isolate commercial instrument, traditional high the structures. global is emerging blood to

be important will susceptibility using loyal factor testing in success. rapid Wave an Our customer early currently base

in leveraging the strategy starts in existing Our and our position market with PBC customers new and EMEA. for commercializing Wave U.S. the with

Secondly, market isolate research. and offering increase by into customer susceptibility the engagement will we testing new expand to market assays

regions beyond Finally, the apply imaging areas we technology testing. enter holographic to will and EMEA other our and of U.S. diagnostic new

in first strategy step well underway. to PBC is increased leadership extend penetration with in our market The

to secure continue long-term susceptibility contracts testing adopting existing our to rapid our accounts We in customers rapid interested XXX-plus and of susceptibility grow testing. funnel

existing a to data economic partner, partner. Our further Wave is next and and on strategic outcomes step begin clinical commercial champions. developing market a will global with increase access we our build early With

wins platform sets our positivity. Launching Wave and a converting to quick our but for overall cash on flow reduces base provides path a burn commercial and also existing us installed cash

PBC a strategy and The share results. commercialization XX platforms missing menu same second of isolate customer up to patients. the results our wallet on in the to step isolate report expand in clinicians legacy either lab X hours an discharge cases for to producing is or by already hours in critical most than Today, susceptibility instrument therapy window greater launching adjust

with patient [ markets EMEA antiquated bringing comparable trajectory can same platforms, legacy shift into for isolate to expanding improve outcomes. and another structure finally, geographic the results true By cost growth footprint to a customers our by beyond replacing systems. U.S. ] we affords And Wave begin

see along as Additionally, we to opportunities the Also, microbiology Wave's such imaging assays expand pharma. testing. anaerobes applications see and completing potential early, with Wave antibiotic holographic yeast while with microbiology with beyond development of we technology other capable still

update a to on for commercial Now secure work for partner quick Wave. strategic important a

a As our is mentioned, partnership Wave. sign strategy of an to important part to global, commercialize strategic

midyear. strategic our strong diagnostic There have discussions is be it diagnostic the Wave strategic to with result partners' Over interest and microbiology building by accept partnership potential ID several in past solution. engaged highly Wave sign partners. will several a we will from for any to confident months, source, multiple the portfolios. we an remain we be pivotal block can numerous making complementary microbiology able

moving to Now Arc. on

deliver for the completed for with recently remain samples. labs have consumable. of instrument identification with summary, yet commercial Arc MALDI automated We XXX(k) the cost-effective In and encouraged rapid our microbiology for PBC and milestones of submitted providing We prospects our next an discussions application our are we successful confirm Having on optimistic the exit major next are months. very continue development we potential market and incredible about set Wave, XX the to Wave. to achieved strategic

and Wave covering result X.X needs testing. meeting and of an of At all hours I'm a platform from this menu complete PBC time, will the set to our for isolates, take laboratories, to AST new in a questions a With average of time scalable microbiology happy analysts. both standard any

Operator

Our first Craig-Hallum. question with comes from Alex Nowak

Conner Chamberlain

you for sales you maybe incur? is describe think the Alex. on This Conner well? inflection then it Or is we is a it start to well going to how partnership is can BD when see maybe struggling? going? on your And Or thoughts potential begin maybe Could

Jack Phillips

of couple thanks BD is Jack. Conner, the things. the a This Yes, partnership, so question. for

it's First of all, active. very

all continue with and relative work to sales We to fronts on BD marketing.

we in previously, that the once something first was we Europe, we up mutually I Europe got mentioned wasn't BD, us agreement off, success. into that market, it mean, realized I with that had that As for setting we agreed commercial the

ago puts tenders. We BD on new agreement that signed Europe participate European we to And quarters team us for glide several better now, a agreement. redid in much that really for a path the

business submit broader in the and those the as Pheno can BD, in for microbiology include So Arc of the tenders tenders. they Europe they now

well, back as transitioned we went that's several through put months but that. So we were and going

QX. production the been ongoing very in in training more many in with QX to shifted into productive funnel and of and successful, to continues new disappointing momentum And had resulting more We're those really, we that's brought We was closes the and U.S., BD placement into more I'm the In happy getting those deals team granted and in, continued in build. but growth. say the QX. sales We've quarter, sites. training account

positive. So was that very

to continue in the other is then the piece And opportunities we progress funnel.

Arc the Arc ready filed last the and So we to would to as that the already is and to Happy say now U.S. team that, start continue bring closer as FDA. The to close. positioning them opportunities, say go we I thing is to mentioned trained as in well. we is ready get and with

Conner Chamberlain

up potential maybe walk well? have then that through launched? of as And the maybe could you it's frame Arc Great. could the impact And pacing once

Jack Phillips

Yes.

broadest So fills platform. really There that platforms the big market it's serve reminder, need -- the just very in easy-to-use today I an the the thousands need market. mean, a Arc identification. on broadest menu, in many of important an clinical it's one of a It's MALDI are

of a challenges One though, identification. an with long the takes produce time it to MALDI,

Again, Bruker with with in one Bruker, Arc to both With we but agreement in did traction behind, a on Arc, approved on have then close we We've as this, for capitalize in into bit deals that XXX(k) expect U.S., Biotyper the codevelop would we really and the we be an conjunction our partner system Arc. I Europe as said quarter in Europe. good forward. move several the X to got before, we're in opportunity

As FDA And and what but aware the the not Arc already and we're doing MALDI the in marketing the for X-plus FDA, very get from there's the Arc turnaround U.S. we're approved results it's in a MALDI of overnight careful we getting to making we market so hour sites our is time. market, move prepared. customers about in platforms are Arc, U.S., to big expect things for identification once we in customer basically opportunity a many in because plans tremendous

Conner Chamberlain

else terms Awesome. done what's then more been up traction there? drive to not in what and be main kind system hang of placements of getting And then with the placements more Pheno can

Jack Phillips

to like next gain I said, starting were mean, last year year, mid-year I Yes. more traction. -- we

traction gain AST. to microbiology process many, The challenging the pharmacy with to care across the docs, It ID with We system, to strategic functions health continue many C-suite. rapid within the stakeholders many involves both BD. remains selling

And so our funnel build. continues to

opportunities with moving we've and said, challenged been funnel Like through I decision-making effectively. the

team partnership that did because organization, need a cut of one maybe also, in in We of cash restructured trained our to that of little and speed. BD to probably, drivers time. the last the with BD more probably result change organization a quicker to did went the their of that and up that's speed sales the And really burn, year. early a lag we burn marketing through taken to were. we in our and And getting thinking as we getting that and traction that we they And really our cut of that's cash we and BD, be and really up would bit hindsight, kind than biggest

sure a sales is in come this the one And just to to most takes of sale, complex it diagnostics, complex up for And it's time in speed. microbiology.

So and about we're we're excited see where moving to we there, greater headed expect forward. productivity

Conner Chamberlain

final design more any then to Is on do there All Wave? right. That's of helpful. more And work here. one the left

Jack Phillips

No.

we've down design we've locked So exited development, and the Wave. so development on

locked is card Our well. as

that And we'll in good Wave to another We're we to very really one just We're a well. our start. site, and site completed. week have preclinical are in hospital in in thrilled going today. are Things off or is is laboratories Software be so study. a

clinical, But course, up major we changes Of any initiatives on we go we we do and that update upgrade may software, need there's as to Wave where go always like approval. that. through chance development through make leading to or anticipate not to FDA preclinical

Operator

The next Brackmann question Blair. from is William with Andrew

Dustin Scaringe

This line is Dustin for on the Andrew.

talked First know about I question you've us. releasing data. the for in past,

saw from what with I some in area on plan you're Wave? the one was think preliminary back we then should data if still of we metrics submitting expect to And how ECCMID that's different But this there case, going that. the be December? performance should

Jack Phillips

Yes. Great.

plan Yes, and our put Again, when clinical to submission thanks, will as we an do into releasing possibly through dependent that to we're that and we our So some preclinical data trial. release be that able on submission. lead FDA will FDA up ability data so to on embargoed data we Dustin. be also of do

intend where said, the Wave. for fully we're that data That we on seeing to be transparent possible,

that of end selected You're technology we Accelerate And correct. of actually of And for been data holographic one a capture a of actually -- our in presentation breakthrough system. format capture on the scientists have at conference, the here posters in an we've for we've ECCMID is be imaging for Wave, couple at image And use our been at that key there. will and also we'll Wave oral on presenting Barcelona. April microbiology.

time-to-result and release will you So we asked to that then related submission. releasing we're the with able agreement, continue Those really FDA we'll about do appropriate excited to in to so metrics. agreement, that categorical essential metrics, much key be our about area, and all we're will And this metrics are be that. alignment as very as metrics

Dustin Scaringe

Understood.

FDA Another you on the how there positive the the like would question approval that gram-negative blood isolates. culture blood Understand long thereafter? process positive take with and after would that look pairing get culture. What for

Jack Phillips

Yes.

We than gram to for our or menu first, as full It's on panel. I've and what we strategy the So a submit, much it menu. menu today relates surpass will we'll anything be going customer is, Pheno look to on gram-positive upgrade as existing menu the clinical from so. to Wave as for robust by have us it allow full mentioned, PBC trials that's with that's an way. that ultimate negative It's of submission. and important The to the a coming what the market to more positive Wave next be will well. samples that's menu as acuity do And Pheno our highest out to to will also like menu PBC, with it's we focus feel base round blood full

to for once that go on for and working ready menu submission, Once -- has And then work that gram we've already we'll move a negative off we're way development And moved development then as submission we full gram-negative we'll then to lastly, will we started. already parallel, that development, ready there. gram-positive get through quickly there. then menu. gram-positive we the it get at that be look gram-positive beyond as isolate isolates prepare in And by

want back that quarter dates don't to to menu, to and I the goes, on timing as trial plan in X. far first now. complete right we FDA to But as submit clinical again, So release gram-negative any the

likely to in submission trials year approval after have then expect gram-negative. FDA and expect gram-positive, we as and And clinical we as get sometime by We progress 'XX well for next to FDA get to gram-positive approval. midyear continue

is Beyond launched. when menu isolate be will that the

Dustin Scaringe

one Okay. the there. I detail One appreciate last for David.

to commentary on any this where burn Just end spend you we and up? can year give can expect

David Patience

Yes. Thank you, Dustin.

debt our XX in XXXX know, and a you we cash in burdened not burn the initiatives have lot reflect the focus of us, initiatives the in and meaningful quarter were extension cash the for to well can confident first reduce further as as burn quarter. of significant debt, these related months. with amendment since many burn. amendment that million $X our have that year has fees. past We're fourth third a you over the But As and extension with seen of the half Overall, our reductions been as we legal restructuring over implemented saving does we cash quarter-over-quarter

For in me. the clinical see compensation into averaged example, moving and -- in we've $X portion excuse heads XXXX, a noncash program. quarter, excluding million exits R&D, Wave reduction significant as of We the into approximately program development our XXXX

focused forecast when quarter, significant muddied SG&A about both We're fourth well fourth in mentioned. But the 'XX months. reduce XXXX second reduce savings going the quarter SG&A, a million had cash we been bit quarter XX per as well given we're we modeling as for in past good into $X cuts in points and the off made the to restructuring. are debt fact the quarter jumping cash as starting the we've further SG&A again, burn on then have So of spend and those our continuing as to as to think look that over

Operator

the question-and-answer back session. remarks. like This for Jack call concludes to Phillips closing to our turn I'd

Jack Phillips

just the we important such care wrap you, few sepsis today. and an for and Diagnostics space X today. call of that and your to and I that and a XXXX full important becoming on quarter joining Accelerate everybody, year want doing more continued Appreciate in AMR, the health we're the area Yes. interest Thank work items important. in around up more about talked

for we'll for of trial samples. all, is run clinical Wave. with to looks but X today. great very off of workflow The system we already are results very preclinical a optimistic the in The We've just yet good laboratory about a we've and number running results are running been days, we're come, First see. start about our a to the

like And we're QX. thereafter clinical X in and track then very followed likely FDA by the to on much start sometime we feel submission quarter in trial

work done a of general. and the disease market, for prepare meets a we've way in to that significant in and the infectious microbiology ensure exceeds we reminder, needs really As product market as this the

to are With right one interviews, proposition the continue deliver consolidate research to we value results positive isolates over the market that is ability XXX and on blood to for The ability Wave. confirm deep today not delivered of also a and X.X resonates hours; in around we've and driver with. is major at value with scalability the X, done well microbiology the research customers market platform very all workflow that in menu; the proposition the

continue customers, Pheno, Wave. them of We to many as existing Wave contracts are to our extended looking move already on and to upgrade prepare to to

productivity is around that we FDA already for see continue exciting to Another U.S. increased team is the Arc to The expect trained and abroad. XXX(k) BD to announcement BD ready and team with and Arc we the in sales go, approval. submitted

partnership Our Those good mid-year. commercial And track a burn to discussions priority. the strategic beyond cash therefore, of continue. reductions. good, sign track. partnership quarter, Every and specifically on by for This Wave continue multinationals. agreement make progress, progress Pheno discussions company, job we continue with burn major we're remains cash is our quite did global initiatives. a great they're on We've David for and long-term Arc to had outlining to with many a partnership important

work to got take us. doing The employees progress a in that We've our of thank milestones for the very about mentioned. across you all the the quarters We've And of laid I wonderful that the closing, want Accelerate these very is really and and in, excited lot for board. I've made in we'll soon. great out tremendous we a they're we're then areas excited in much moment And tuning that deliver team talk today. on you XXXX. to to Thank work ahead at remaining

Operator

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

You lines. may your now disconnect

Accelerate Diagnostics (AXDX) 28 Mar 242023 Q4 Earnings call transcript