Earnings call transcript Q1 2023

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

Operator

Welcome to the OpGen First Quarter 2023 Earnings Call and Business Update.

Before we turn the call over to OpGen’s management, please note that any forward-looking statements made during this call are based on management’s current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. OpGen does not undertake any obligations to update publicly any forward-looking statements to reflect events or changed circumstances after this call.

For a discussion of factors that could cause results to differ, please see the company’s filings with the Securities and Exchange Commission, including without limitation, the company’s annual report on Form 10-K for the year ended December 31, 2022, and its reports on Form 10-Q and Form 8-K.

Joining the call today are Oliver Schacht, OpGen’s President and CEO; and Albert Weber, its CFO.

to call like for to would remarks. introductory I turn over the Oliver Now

Oliver Schacht

And all thank time operator. you, Thank you today’s to for call. join the taking

and opportunity We Q&A a provide have pleased and this are a follow to Session. business financial with update will to

the call, OpGen reaching quarter late increase from revenues. Innovative believe the collaboration year our milestones that milestone FIND. And in well announcing terms project the met upcoming first as by XXXX position key XXXX per triggered Diagnostics near-term and the to New Curetis we several of on We last started achievement On continued have the in for commercialization off our undisclosed carried milestones, This a subsidiary, good agreement. catalysts, Foundation of year-to-date. as is or with initiatives. a an we discussed Business key payment advancements into

and all the that planned. our excited announced we collaboration completed and recently milestones achieved accomplishments successfully deliverables key We’re FIND about as remaining

In identification welcome granted the Chinese a resistant diagnosis We addition, in antibiotic that by they decision portfolio. we of covers patent patent strategic Ares were subsidiary, of China. The of patent the our diagnostic variants our office value for key use bacteria. genomic it the announced the as believe the and Genetics, Austrian accentuates intellectual property

genomic. we on improve AI our plans will menu next-generation business. new this our support to QX data XXX,XXX to to expand and from database also predict that continue over accurate NGS year location. service The growth Vienna executing to the We help is growth in moved our sets With move of data positioned XXX,XXX that a alone, Ares of in to susceptibility or milestones believe we announced one well several from antibiotic plans of RSDB are sequencing Genetics models our recent product further and for asset sets

He Officer. to results the Albert will and Albert? call first for Financial Weber, XXXX will quarter OpGen’s Chief turn over the developments, of review now I financial financial recent

Albert Weber

on the welcome I guidance And our highlights Oliver. of discuss thoughts call. the and to will remainder you, the quarter Thank XXXX. for everyone financial results and and first

OpGen’s in for XX% first approximately contracts, Ares under we project, XX% $XXX,XXX, to of increase company’s the XXXX. revenue approximately This first collaboration revenue in the over increase increase revenue $XXX,XXX an of to first of related primarily as XXXX we quarter revenue generated $XXX,XXX, sales, XXXX Unyvero fourth AMR XXXX. was quarter a of achieved quarter revenues. as the Compared was of our well due service received revenue the from product commercial Panel Acuitas the Gene quarter FIND

existing upcoming we customers. XXXX collaborations from quarters continue agreements generating as on as to commercial For in revenue and work the will new from well

quarter operating expenses XXXX same in million our total operating to our at in XXXX. the for Looking the to compared $X expenses, of quarter first decreased $X.X million

Our previous first pre quarter million a corresponding year, and $X.X R&D to the $X.X i.e. XX% compared million or over period expense research the of was XXXX for reduction. the development

expense G&A was million of million year the X% period quarter for $X.X corresponding an general or previous XXXX to first or administrative reduction. compared Our and $X.X the

$X.X million expenses compared $X the consistent XXXX Our approximately XXXX. fairly million first of quarter and in the quarter of stayed sales at first to marketing in

cash consumption its approximately while We to first of position position. cash had a quarter to and closely with of end we of at financing million. cash The XXXX, end million our evaluating turning Now potentials future rate XXXX also monitor the company opportunities. as approximately $X $X.X continues cash

May proceeds, public X, $X.X of announced with $X.X proceeds. offering of and on announced a we of January, million another million recently with the the gross closing gross In we offering XXXX, public of closing

sales customers AXX and the Ares invest following: U.S., the Genetics commercialization and for Unyvero and outstanding Unyvero sales commercialization support service the indebtedness commercialize collaborators support a company for marketing to in repay continue its on database infrastructure and and AMR of products, Panel invest of products, been in services, the FDA-cleared efforts and platform and Acuitas AXX offerings, for the have with We and Support to tests, using and focus products Gene and of diagnostic and the of certain development these products related continued our to offerings direct continue to operations manufacturing our our the further subsidiaries. be the the in from test proceeds and R&D platforms support

have debt XXXX pool we million now respectively. calls, from interest and €X year. due and of of earnings April There this obligations the repayment previous June, tranches XXXX only first in on additional tranche mentioned and two accumulated by deferred plus June, met our principle €X debt become in EIB that As million, our are

be continue an We the repayments. the about in to potential restructure with active upcoming EIB opportunities to dialogue

guidance per an year call our reiterate in earnings our operations of March we revenue range to to expected our consumption from million the of million. quarter $X XXXX time, cash year full at net end XXXX million an $X in $X.X of million expected $X for we provided this that full around At and

the partnership and products in genetic our especially distribution distribution the We and see after our later as continue revenue this here Oliver Unyvero details share on recently closed with opportunities products Healthcare services this to you growth Fisher for U.S. of some having further enough. for will our with call. partnership Unyvero globally,

quarters momentum Unyvero in building partnership and We U.S. see distribution and the sales expect universal the under this traction for to beyond. our in coming

further with contracts U.S. the commercial new are Unyvero in here the progress signed good Unyvero the rollout Systems of and Acuitas both recently products. also customers making and placements in for have We

our Ares during consistently as on the for routine now Sequencing quarter Sample repeat Services second offered team. has quickly year. of in have in also seen into local customer market weekly U.S. first We with the orders and basis the processing a become this coming being well

indicating potential for to growth our customers Taken funnel OpGen. dollar annually has clearly revenue value together commercial proposals significant substantial with

recognized from the in After $XXX,XXX revenue we first recognized $XXX,XXX XXXX. collaboration quarter FIND in of in project from we the XXXX, this approximately in more than had revenue

of countries With the $XXX,XXX first the teams approximately first of already phase, The the FIND of in another has potential Curetis samples initiated this and full packages a new LMICs. expansion discussions and on a antimicrobial second development we product at the quarter. and an additional and blood middle- test follow-on in at looking the for or anticipate for work contract of AMR – project recognizing culture product phase income or low- resistance

System submissions the and countries. road approvals launch XXXX, sales LMICs generation have we the Also, first for down in collaboration commercial trials, market placements, quarter preparing trial. their seen This regulatory as our during under the specific cartridge clinical from these BVXXX for would and seeking include revenue needed BioVersys pneumonia and of clinical initial Unyvero for

added come clinical recognition systems online revenue and as to further that be trial XXXX more expect expect progresses. during to trial continue collaboration as under grow XXXX their and sites We and

Non-dilutive opportunities OpGen... for financing and and in option multiple Unyvero a financing remain I priorities with – sorry. strategic AXX around opportunities Ares Non-dilutive a for hello? continue, remain priority strategic opportunities various already submitted

Oliver Schacht

dropped? can Operator, has check line if you his

Albert Weber

Hello? Hello? hear me? you Can

Operator

We can hear Albert. you,

Albert Weber

preparation. provide will submissions opportunities opportunities Unyvero us collaboration these with European of that and opportunities complement FIND, funding's It financing key Non-diluted multiple submitted stages funding for opportunities We partner the additional none other Okay. continue. respective various in to Ares look potential already with with these organizations that equity and our I'll BARDA, and for AXX for funding non-dilutive Oliver? bodies. remain non-dilutive XXX% of in opportunities strategic around of extend and funding Then understand is to Union projects. further like funding OpGen priority a allow to full review

materialize. ranges. XX% is that to therefore provide in OpGen's vital to otherwise the non-dilutive sheet such Typically, funding XX% co-funding's from funding It quotas or range balance not somewhere would as can XX% maybe ensure likely

concludes the financial update. This

to I will call the back now turn Oliver.

Oliver Schacht

Albert. Thanks

turn Before part Q&A, project far would interim as Curetis I recently like completed to to progress in the under two quarter XXXX. milestones so InfectoGnostics the of highlight second PREPLEX with brand. our OpGen of the collaboration we

which RSDB pathogens work and This could project, the PREPLEX of two additional which markers the coming allow identified Health provide in of could conducted years. novel dollars being collaborative also on additional proprietary for were were using markers These database. funding concern During confirmed this thousand under success list. World the of project, validated a our hundred Organization's are few

and packages, signed clinical marketing We will In to the of with fall of the our high the expansion volume increasing forward R&D April, classification we're for UTI Work $XXX,XXX XXXX. diagnostic for the the following work closely a successful FIND, authorization granted urine the Novo marks our for working De UTI which collaboration seeking a collaboration review become revenue. the milestones completion a under in started expanded trial. short-term molecular in FDA our project to the to about This Unyvero hope we test total FDA, multiplex major to three FDA. samples which panel, with by the request completed will submitted of by interactive we during Unyvero be already first panel looking up originally

into Panel Scientific. submission April, were reviewer submission on FDA initiated clearance. on that review. that we the The the AMR they Fisher Thermo FDA closely reviewer who has UTI sent substantive Gene learn and entered agreement lead of OpGen We announced their in Healthcare, has lead recently have Fisher a non-exclusive with distribution a the submission worked pleased be the confirmation had OpGen that with is the Acuitas already same to will and complete Also that Unyvero eventual part

the and Fisher's commercial in Fisher infection, the The research position as for it markets. increase in strategic as agreement U.S. urinary very due and FDA-cleared partnership platform tests future. test strong is AXX our we presence to we with expect which in to its for the for believe Unyvero Unyvero will relevant platform, the about diagnostic the We're excited pneumonia tract OpGen's footprint AXX become distribution use-only vitro of distribution as bacterial currently across well

process towards Healthcare of growth Unyvero achieving the sales Since in accounts target Fisher has adoption many believe for expansion We years. our driving hospital the commercial with of streamlined. cycle onboarding objectives already, that be the relevant we revenue a in and this be to the is step the potential U.S. existing strategy and shortened there channel coming commercial the view as in to next our contracts

has where otherwise license up other this monetize a with several specific the quarter there for possibly support and partner of first China, out announced we with milestones during business corporate for a the to is to In firm campaign in believe opportunity we the teamed business. A or an platform. quarter to strategic the attractive advisory second key year. development we've achievements over carried to include, April but momentum AXX alone, look Our Unyvero few AXX

they platform, China. Chinese be now launching our After Unyvero the AXX corporate completion that around outreach are partners on of strategic their list deal target a a for in platform identified strategic of due diligence to the might interested

We our Administration forward and studies for or with May, their existing meetings are Chinese AXX partners and by the submission in the and month NMPA. contact move prepared platform, to work weekly Germany towards including the China review for they during both our a upcoming National in of Products continue clinical in-person with final Medical

We We We milestones, our expect to NMPA our commercialization approved catalysts continued our on everyone believe XX advisers obtain the and forward the partner. on to revenues. the somewhere to process path product, guidance existing developments. around sets from a clearance per updating with near-term increase take OpGen of Chinese to months to regulatory XX overall OpGen's look along from to

your and support in for call. afternoon's this continued participating you Thank for

like questions. the I for turn the operator to back now to would call

Operator

with first Hemami your comes Thank Our Pooya Please you. question. question proceed Edison with Instructions] [Operator Group.

Pooya Hemami

you much Yes. thank for very my Hello and questions. taking

possible out-licensing First non-exclusive of through a announced a upside explain the us Thermo some the of and from bit to agreement recent strategy? to self-commercialization with of Is also saw Fisher. it from potential maybe distribution with change we the the all, walk shift strategic

Oliver Schacht

Sure. Thanks deal. Well, that was for question. out-licensing this not an just clarify to

the of upside and deals. end This alongside our distributor, at distribution is from We footprint addition coast who downside broader Unyvero market and here an here the to and add broaden mainly decision the in at agreed-upon to customers. segments no and distribution U.S. sales the sells i.e., in to internal see own our in channel the coast driven in indirect of OpGen here transfer sell turn efforts. price classic our to feet desire our products absolutely the distribution faster partnership to to significantly relevant to deals was penetration marketing U.S. street the for our an by All commercial on products the of obviously in are and we products deepen

Pooya Hemami

that and good what hear far. some so? good FIND the give It was just the thank you also or over results collaboration color Can for can of to clarification. expect steps us R&D we the quarters Well, the so expansion about you help next you. next Thank that reported on are few the

Oliver Schacht

Sure, revenue us collaboration, sure. allow in I to packages quarter. Indeed, in mean, continue added generate we and said, the work $XXX,XXX as up second to would the the

parallel, ongoing an we about next discussion new partnership. a of a in contractual have relationship development the phase and While potential

remember really with about FIND You continue thoughts from different as facilities projects, the of forward dialogue throughout FIND this lines work time remaining this in a Curetis phase the our to well discussed the in stages with expect our coming as terms path We've team and the potential weeks. quarter the Germany and in recently scope. first discussed packages shared and team was phase. feasibility at the potential next the met phases, progress the and We

Pooya Hemami

bit you China clarification for that. China should Thank clinical you us you just Unyvero? opportunity. had mentioned Can about in a on give more maybe for Okay. bit we your when remarks much a trials the And expect very prepared in

Oliver Schacht

is we Well, at from very experts They do at at all can in that as operations this been OpGen at the in person several since I be say and with Beijing partners China as COVID that actually days clinical meet three a has of this This XXXX the this clinical trial site is meeting team point time and in our with weeks. Clear will have possible. well moment. coming in on-site first of sites the China started over or

– possible Beijing Delegation and our here China as Curetis' communicated. of from. for Also, all what visit month the the update this facility of sure meeting this, We'll news really huge I discussions in these is and facts steps an I'm progress Germany and may be our in partners we Germany coming study around clinical can the from where which there that face-to-face and in have getting from are offices as next in center excellent look during three the way and provide months that in years, that's Senior here come will that become first time we're But at the week. CEO soon Clear terms initiated. over May, is the weeks the later we in both manufacturing

Pooya Hemami

very thank and on Well, you congratulations much, quarter. the

Oliver Schacht

Appreciate you. Thank it.

Operator

Thank you.

Wainwright. comes with question next proceed Our Please from Yi Chen with H.C. your question.

Yi Chen

questions. you My do you UTI And the the the Thank my expectations you could think frame for possibly time your Hi. it Panel? clearance? taking could review first question discuss secure for marketing regarding is; when FDA

Oliver Schacht

Yi. Great. Thanks,

XX to letter. that is – from the within have with days typically clearer obviously, AI letter on called feedback. on. on what’s I typically would us Normally, of picture the review we’re to We process. that, much or wants formal take Now topics FDA Once again, types have we an mean, the to substantive going additional get that would all FDA of expect focus to go back sort and form to a of we the get the information request

months. from previous from XXX(k)s, fifteen nine de can whole of to mean even this or interactive I twelve certainly anywhere take process novo review

be probably a much So XXXX that a again, get now once say the weeks. going I picture right But to have we’re and over first coming here this decision. to look formal it’s would we going carefully response at clearance clearer

team the to lady Again, her be worked she And to known that during a and process. Acuitas entity working reviewer, the lead very we that we’re as us. the whole closely the good with very, news with going is is

short and a communication this is as again, of to name quickly as line game. the to things to So, is by as us is the standing hopefully, agency time good team on question from that is be there drive the the come as And they respond really open turning which, possible any channel, mutual going quickly feasible. a around as to to back

Yi Chen

does it. to the Fisher your partnership team? UTI the need will once Or the just And you rely Panel Healthcare? with own clearance, Got increase to marketing on OpGen secures it market sales

Oliver Schacht

question. Good

UTI. first to commercialize wait of to So all, going not we’re

in PCR with that to in portfolio We’re research the lab universe of as we Panel. only. urinary UTI an already and the the would I actually actually PCR Fisher are standard was customers Thermo franchise a commercializing today a infections of UTI have growing given And clearly have use an sort open that that one products UTI using platform of active Panel tract healing venture kits. the they

kit cartridge-based So, to having a sample-to-answer key. was them

We internal out from marketing here do not the organization and on U.S. our in own anticipate growing sales

focus marketing and is an more U.S., clearly, team accounts, than expert to going is the folks instrument organization strategic times and the anything in molecular use our are coast, in So, literally XX size these commercial diagnostics government our generalist our is from sales be of to sales the what to to coast that accounts, to leveraging to whole specialists. in

So, teams working be on the Fisher to of there’s series side. that a going we’re whole with

we by to obviously, expertise, help Fisher. So, the look contracting bulk would really be and driven products, Unyvero deep customer expertise, going platform but be of forward of Street end also the on to and feet domain with, them the selling accounts clinical the them Thermo have around knowledge the primarily the technical really the and

Yi Chen

would for customers? customers And terms got Gene has discuss for new lastly, it. And in new AMR Panel? could of Acuitas you be expectation what XXXX Got onboard many the how your

Oliver Schacht

We’re of any customers. not individual specific numbers providing

the us drive anticipate to the base will the As the first going be again, focus Fisher grow primary I commercial because, relationship installed couple that the that’s we’ve through focus. sample adoption got Unyvero of That’s the Thermo on XXXX platform to would and to answer. But list. our for to I primary Acuitas. said, be accounts

going the at So, continue a to Unyvero much broader accounts rollout the Acuitas we’re on side. look while we side, to add individual on

Yi Chen

it. you. Thank Got

Operator

Thank the Oliver you. I turn That all to we call is the back will now remarks. have today. for closing time

Oliver Schacht

us for very today. joining on of everyone, Thank our you, Please thank Investors filings the Well, updates SEC the visit much. or company. you for section website our

Operator

this that, with teleconference. today’s And you. Thank conclude does

your time. may disconnect lines for this your you Thank You at participation.

OpGen (OPGN) 15 May 232023 Q1 Earnings call transcript