OPGN - Earnings call transcript Q4 2020

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Operator

Welcome to the OpGen Fourth Quarter and Full Year 2020 Earnings Call and Business Update. At this time, all participants are in listen-only mode.

Following management’s prepared remarks, there will be a Q&A session.

As a reminder, this conference call is being recorded today, March 25, 2021.

Before we begin, I would like to caution you that comments made during this conference call by management may contain forward-looking statements regarding the operations of and future results of OpGen, including its subsidiary Curetis and Ares Genetics. be review without with recent factors limitation, for in that statements. to Exchange Securities Form forward-looking that you SEC, the materially XXXX including, the from results Commission, the will to may encourage cause OpGen’s identify or the filings and XX-K which actual I will with events specific differ filed company’s described most those the ability expected include, results from Factors that strategy. to are limited business successfully to, the achieve and the completed may company’s but our Curetis to synergies not the company’s with combined affect combination implement company impact COVID-XX global pandemic the operations. and business The of on continuing our

of warrant is date date our conference proceeds the of XXXX FDA such events and any and no as except exercises reflect and commenced of of providers from live of of the statements and success this offering for undertakes update the this regulatory conference at-the-market the strategy, services. of obligation law. in with required existing bacterial XXXX. other The November in competitive use content The XXXX and requirements by as Acuitas call, as circumstances isolates only and in that XXXX particular. accurate that of rate factors. for commercialization on or and and the COVID-XX company call in our after for this February as use or healthcare situation as Pursuit time-sensitive general, AMR pipe Registered well other efforts and partnering products March new revise Gene our by effects pandemic Direct. the we as recent business and the call, other information hospitals adoption economic contains XX, to The to as Our for well February current clearance our financing Panel the from for The services products proceeds

and Schacht to President CFO Oliver would today to over remarks. Joining OpGen. I introductory the like be CEO; now Oliver of Dec, for and call call Schacht, will Tim the turn

Oliver Schacht

to decided by for next you and making Curetis Evan Directors Board possible former commitment to of continued thanking call to the meeting of years personal him not on a tremendous OpGen his and this OpGen of our him stockholder in thank of afternoon. combination to Jones, begin like company CEO dedication reelection endeavors. upcoming XXXX. the strategic Thank to us I and Director everyone purely his would has seek and currently joining Evan this reasons business for June. wish in his at We for success in the for

that present. aware, highlights allow with ended call were last as still evolve, over and solid assets, combination differentiated the wrap financing update strong you’re quarter the all On from driven and top the our our activities. this, portfolio success very point, opportunities business make pandemic business growth. unique significantly. and the quarter, business, call XXXX, are investors and discuss product I we is review across made we’ll begin relate part will an and partnership quarter today’s diagnostics financial then combination position tremendous the of that vaccination reckoned full recent initiatives strong be of able will force fourth support and us molecular post This revenue at significant our prospects, We then to Tim products diversified growth grow as pipeline and of efforts and that portfolio the to up to capabilities they by the pipeline line We’ll attractive call, is progress the and an proprietary and briefly showed key execute as product the with reviewing on targeting continued have with XXXX while the with and AMR or to has outlook. our today progress company’s cash global business front, the pass continues as on antimicrobial a a award-winning on established which the to the to year being resistance. effects will diagnostics residual highlights a As recent there we note on bioinformatics Despite core in and strategic space technology reprioritization by well to our company’s status and and a of announced

last includes and and portfolio, a in XXXX. discussed focus company bioinformatics resulted from following platform outcome the firm. tract leader subsequent the survey the expanding on complicated a urinary market to in decision-making being by feedback conducted of platform reprioritization company’s and reminder, voice this half interviews. new invasive submission we of infections diagnostic a quarter, U.S. trials analysis in They clearance on significant of platforms As opinion Unyvero renewed joint a second including future customer research The infections a anticipated with to This of start key consulting third-party taken feedback for in XXX and unique the of extensive the and and number and product proprietary FDA reprioritization the of include capabilities. the a measures clinical application stakeholders the

XXXX. in other month. using UTI first in two meetings of identical products Unyvero successfully these both Europe will materials are corresponding platform half clinical earlier CE-IVD Unyvero the been with indications the on the just types sample and possible available package and markets. having FDA developed products pre-sub have submit marked of and this Similar commercially today the first presubmission for submitted on Actually, We each during for a

time. solutions powered focus with over savings rapid susceptibility, a offerings Ares and an and The focus significant will has bioinformatics be also prediction diagnostic artificial included to our on including realize platform platform increased next-generation AST based synergies developing antimicrobial Another and sequencing AMR Genetics molecular key resistance, reprioritization consolidation capabilities. cost operational intelligence

fish in of early significant successfully down schedule the of first delivered globally, of We the have early fourth year lifecycle reprioritization, PNA by completed wind now. in and XXXX and this sales we in remaining XXXX. part of product legacy revenue quarter FISH the QuickFISH end-of-product As the ahead discontinued quarter and the have including

We will sell manufacture FISH going or ship products nor no commercial forward. longer

is can over in plus three-year by market product a significant one numbers second of amounting Unyvero has which for and XXXX, the committed it As excited Unyvero half Annar Annar Colombia platform, our we In application the the renewed OpGen’s at be for to systems Unyvero expanding introduction an is registration, on in quarter. term, announce relates system leading that a Bogota initial expected has of in Curetis Cartridges. application and with term with distribution line Colombia. invest diagnostic and cartridges and AXX partnership were has focus be the fourth agreement, year The into distribution full already global responsible that significant Annar to to Colombia. Health minimum obtained total purchases initial return, Unyvero renowned product instruments of headquartered to committed entered three instrument of is its cartridges to extended Under the commercialize disease the in infectious the IVD increments. Technologies has in XX subsidiary in numerous Colombia’s diagnostics least of agreement Unyvero the has years of Annar significantly distributor rights Unyvero suite to Annar is manufacturers. distribution Unyvero working to exclusive of

partnership thrilled commercial for alignment strengthens and swing We’re includes and Latin during related with products the growth registration our full KOLs this with and of leader our America in entire OpGen the participating opinion commercialization as strategy. is preparation. as key successful in it is early of held, AXX Product which Unyvero presence was core part in portfolio launch a and revenue highly representatives XXXX, process event

early and better microorganisms. and stakeholders, infection solutions interdisciplinary number One anabolic Pathogenome detection, or Platforms the order cycle the NGS-based an sequencing exceeding Integrating hundreds ARESupa the JPIAMR orders AML The molecular Antimicrobial intelligence and I initial overall joint Assay Ares assay. the surveillance of for discuss that excited will informed We is these announce resistance and drug potential need globally to based like believe methods of launched microbial laboratory commercial provide novel initially anti-infectives of combining targeted More network novel for guidelines genetic test received management bulk methods $XXX,XXX. advanced the the and tests, XXXX. artificial this project was recently, we first Microbial Universal of Ares matter Network demonstrate has pharma access molecular support AMR platform next-generation November, Genetics growth volume of orders Sandoz, to guidance markers a of one the generic AMR in the surveillance NGS its goal Resistance, universal Genetics to specimen in activity, subject within launch options sequencing stewardship. hybrid quarter and of then version of It and caused early and announced for bioinformatics gears, another in this would throughout partnering started their of antibiotics life quarter in likely and for expanded AMR has profiling surveillance quarter. shifting digital recognition collaboration for to of comprehensive Health program the Revenue partnership in develop and a the for microbiology supplier joined is context native native with difficult-to-treat established development experts XXXX Genetics continue the the Now in therapeutic of management. collaboration Ares to program we specimen control. fourth also top Genetics infection Ares line or for were the for in profiling ARESupa Ares prevention In and will subsidiary XXXX, capture of with the and to award-winning XXXX, Sequencing of again, extended Genetics by assess by to that contributing year. an from antibiotic

modeling of of with presentation better AST the conference improved November surveillance phase the fosfomycin bimolecular phase at optimal initial antibiotic Big of stewardship. of Data Technologies combination predictive Following Emerging NGS and on based the Genomes, next guidance antimicrobial collaboration silico AST therapies, and in therapy for antimicrobial positioning XXXX, explores combining virtual and from in resistance, potential final the the results

diagnostic of data, a In see infectious to to best from approach recent validating for good United Additionally, highlights us quarter solutions to centers clinical testing. sequencing AST improve practice Applying accurate next-generation best publication publications subsidiary AI-powered in to plan of we’re becoming will in of performance United action further independent The of further solutions Addressing RSDB record, prediction to good FDA Genetics learning of antimicrobial development allowed and from This predictive prediction with validation of by data the genome supporting based potential for first the antimicrobial resistance for working clinical demonstrate development disease machine Ares sequencing-based of whole biomarkers. our practice of PAST. and prediction leading developing genome further the machine accurate practice. the guidance practice to and part practices. currently AI-powered the AI Ares Genetics sequence Genetics to the in collaborators. the leader also proposed to this context, be techniques recognized its antimicrobial several Ares our by the company’s vision States key XXXX, learning into techniques In algorithms globally study was the a patent improve through States and therapy granted discovery moving robust whole harmonization continued whole OpGen studies. on resistance genomic genome sequencing AMR most study adds key supports

allowing choosing OpGen and of that proper accurately bronchoalveolar of suggests fast tract LRT publication antimicrobials, highlighted comprehensive performance infection value In choice BAL and sample lavage management the early panel’s for a addition, stewardship. for pneumonia. study lower and X,XXX-patient clinical multicenter for time crucial to announced to Unyvero from of antibiotics the of significant detect samples, this respiratory antibiotic results ability and fluid also diagnosis coverage The results for successful data panel the appropriate

demonstrating a results, XX.X% ill patients. in getting Additionally, value than strong earlier This OpGen’s to paper very peer-reviewed of journal. especially recently, we published antimicrobial with sample highlights patients pathogen product for clinicians Karolinska in predictive than This inform and provides hours turnaround higher for high time study a HPN decisions, diagnostic negative critically hospitalized of to Institute performance Unyvero data, comprehensive yield from detection. a culture COVID-XX with pneumonia, data bacterial less coverage announced the final five from data

who a Curetis crucial and highlight subsidiaries, important peer last the about XX have play effective is as to routinely publications and inform the line help highlighting publications commercial and they and wide Genetics care professionals, diagnostic reviewed and Over months, rollout of very any its of publication, announced role their product. medical And for OpGen growth health that such novel combat the bioinformatics identify treatment a of help variety infectious and top power journals molecular thus, deliver most Ares in molecular to revenue It efficiently drive the patients. disease. must XX diagnostics

quarter the review RQ platform year who was growth its which full to for OpGen opportunity. to fourth now could to bacteria. One and and Jena the will in awarded XXXX developments addition, subsidiary Tim? two concept development other financial carbapenem for will In Federal Curetis resistance and our applications, the project is future results by Tim Dec, designed turn over recent intelligence-based assay gram-negative for collaborators. Hospital business. present Unyvero additional artificial University grants and project AXX looks veterinary at German Government And I CFO, the the call coordinated an for use financial

Tim Dec

XX to Genetics Oliver, of balance on numbers. XXXX to pro year keep mind you, million, The XX, is revenue XX forma Please XXXX. combination in of $X.X fourth $XX.X guidance. revenue results, XXXX. million December you only XXXX. in XXXX ended $X.X New as the to review revenue of company compared position and to New fourth XXXX, collaboration nine XXXX, for were from international today’s million company months December compared was year as will well due York months today. OpGen Total of inclusion fourth was prior $X.X quarter, due Revenue combined XXXX QX for our discuss OpGen of a quarter ended references months from of only York for with as and XX, numbers X, touch with $XX.X call revenues, recent whereas results XX increase the XX, the was $X.X full the for will thoughts OpGen company, in sales lower QX welcome for months highlights pertain million for everyone closed million, quarter revenue. the was million the on Unyvero for quarter sales up the call, the collaboration by XXXX. million full $X.X Operating the Ares lower million Therefore, months $X.X on financings include On XXXX ended the by and with Total expenses lower XXXX $X.X business as April our the State all FISH to the the include the XX, update stand-alone. ended on as is compared XX, a December full I ended project The revenue XXXX XX our Thank in combined XXXX and for December related XX XXXX sales, on offset and XX XXXX. from a the Curetis, were increase Kit sheet compared lower for revenue Project. This fourth separately. be Genetics $XXX,XXX product to service part the ended largely the period. Ares revenue from briefly Any Department for some offset Health end that SARS-CoV-X collaboration for December collaboration million the months XX, quarter part December forma reference expenses noted combined only to the FISH and with months for and Operating year pro State financial

during were expenses company. XXXX. the $X.X the of million, million some terms to business quarters. $X.X flat million $X.X XXXX. our quarter-over-quarter and three the $X.XX the quarter in combination combination for marketing to numbers the the business $X.X combination million three QX key Unyvero of were outstanding a XXXX shift XXXX. share business expenses in platform $X.XX Curetis program last granularity $X.X compared year. ended XXXX for the for quarter Net for XXXX fourth in loss of operating expenses as and development net XXXX. The full share for in period XXXX. the G&A R&D QX the the G&A year for reflecting expenses per Sales investment million XXXX was Again, Acuitas were $XXX,XXX second $X travel funds conferences groups due quarter in-person would a million $X.X to provide fourth late year. XXXX December XX, to related loss standalone quarter-over-quarter Just same loss the the essentially for compared per driven X. a million XXXX, the third reminder, the meetings end AXX year were announced only of $X.X with not the net ended million halt or with the the reflecting $X.X as of year compared OpGen’s since the fourth as compared R&D in of XXXX business the combination of $X.XX combined as expenses and quarter to per quarter, various in in April year quarters in $XXX,XXX and for amount ended quarter the during mostly expenses activities reflective XXXX, fourth $XX.X $X.XX higher on or basis like combination the and XXXX, the of versus expenses, compared in quarter million essentially quarters million I third the compared the the compared ended $XX the restrictions XXXX to picked in December for year second year shares we the COVID-XX of business COVID-XX the to million XXXX. and the only had from XXXX as increase was lower expenses expenses $X.X our marketing of the ended for third later trial urine Again, and for time to business related in share due and for quarter three the combining the dip of well fourth or were and of up compared second again, since the December quarter was the into combination. with or quarter $XX.X of in quarter XX, second million $X.X combination for XXXX of per was the months XXXX. and $X.X XXXX, Again, $X.X share XXXX last million the million since were year and Since in we of the Sales tremendous XXXX for the flat and million the XXXX. to of and XX for in quarter interest $X months last for million was by ended have XX a the the business a million, The organization. in number

appears during investors well XXXX XXXX. with and continues into Our to story resonated very have

fact, the company’s million $XXX from our $X of to In at market cap over million has XXXX gone roughly end today.

along a of strategically in the prices from facility, moves early registered several During attributable of capital. had ATM our a shares. exercise price $X.XX were warrants excuse QX million, registered of warrant rising strong our of are additional offering have in Total exchange increase highly The XXXX, the offering to and exchange $XX in price we The the of capitals proceeds placed November the under million million moved time, remaining of exercises of or a expects strong the of private of at full. respectively. as of existing with throughout $XX outstanding March million me, XXXX to additional for These an $X.XX long to with XXXX all, all in several beginning February November end shelf we utilization million point and cash of sheet finances. carry XXXX very and raised as today, and through year. to a a that strike $XX have $X.X of were balance to generate have successful an in approximately of Both exercise the company, Staggered million timely From in XXXX. XX.X the this capacity $XX.X $XX.X approximately shares placement the $X.X haul warrants direct today the warrant and company’s – balance raised the exercised if approximately for this were to million mid-XXXX strengthen million company up year. direct at a $XX if company the million

our due and of and parts terms constructed foundation across still specific a COVID pandemic to guidance, forecast of of is offering impact our we In the the challenging across guidance business. continued very from refrain areas comprehensibly for accurate Therefore, will today. the world all and its many

and is I hope provide However, of from will business driver a provide more detail to growth some call. The in areas. now our color earnings May underlying expected major to on our number come

is expected in the businesses grow internationally as Unyvero via as U.S. distributors, well core Our to

We Unyvero commercial seeing labs in RUO XXXX, in XXXX. to usage traction gain by setting and UTI are late in starting are several

driver timeline States. there, pneumonia X.X an seeing have additional account Unyvero Unyvero Currently, minimum a from is the our the LRT the unclear, eight and United approved We’re system, visibility cumulating China. in system would significant approval to period. long-term XXX limited over year of partner for million growth and Bio purchase be committed placements Clear cartridges, cartridge A we conversion BAL customer of also as and time Beijing once NMPA Unyvero

in everyone, reminding place signed and is Just already. contract this

later of our see need specific and deal, partnering Ares and to to of platform is potential around structuring filing Unyvero collaboration commercial partnership on partnering to timing as would licensing negotiations, be prudent Revenue The there highly licensing So happen information depend given last AXX partnership aspects further deal until The this partnering assume year. deal, revenue any and Ares will instruction. negotiate year. on and the potential the of our such not February material would the S-X stage the subject that Genetics’ from it any deals China of no from would deal please partnership. timing

further clear the might non-diluted value funding same the be. we to in deal-based from In is and asset auction we sign to perspective, run, our future under either order not long maximize our prior of to the the for potential may under particular have shareholders upside significant a OpGen been to deal. drive are pressure in cash However, coming generate that to the years it burn. financing generate with flow amounts these we help have product of from coming It the Also, possible Genetics development product And better or the deal is terms value deal in strength determine of finally, a clear we and at ourselves, position possible the in significant and in can to partnering deal what’s point structure. the with future we now balance that sheet revenue. Ares sales the also Curetis OpGen, look type best possible more over might when both and assets of can for cash significant are time a best

XXXX. that, With call platform AXX Oliver Ares from Given milestones. for United large turn and likely Unyvero trial, burn the $X terminated, the I’ll clinical discuss to Acuitas same quarter our into and in being and States and prospective IJI additional key fairly Unyvero time, at cash lead to Genetics the cost million $X to similar investment of and pattern our products FISH for the OpEx initiating two UTI savings AMR yet over further the trials respectively million would urine in expected

Oliver Schacht

some you, in status despite the of and formal on FDA, delays Thank activities, with calls, had received earlier I Tim. in earlier submission, our the commercial OpGen additional issued in programs regarding of to Isolates milestones now the submissions. Last and their previous OpGen Panel agency’s to response XXX(k) non-COVID-XX October, related information as like dialogue requests remained key year. AMR the Gene review Acuitas OpGen’s the and the of highlight has would our upcoming constant stated development ongoing

emergency November, diagnostics in address in submission reallocating for we indicating the or intend from to received they notice to requests submission Following from pandemic. use had would FDA COVID-XX vitro EUA CDRH the prioritize authorization open staff the be

unrelated on to focus COVID-XX within staffing the EUAs While FDA the continues.

pleased we FDA and currently the they very understand end cannot report resources, that our that and clearance volume that or have the to review the Due the OpGen formally to commit resumed the high line. informed time limitations FDA the to specific We’re on requests of January, so-called of review at submission. review timelines EUA Medusa

We information are time a has the as for the that all additional anticipate requests opportunity between resources team’s confident earliest of review addressed clearance FDA OpGen managed we permit. however review and decision EUAs and as related agency’s remaining COVID-XX

While the decision, clearance their commercial activities. we with final steam full towards working FDA ahead is readiness continued launch have

HPN We’ve approval used to to manufactured products submissions our several submitted poised of AMR the launch. of their meet partner successfully XXXX, States data the time early the our have was in and as closely We months already batches approval future regulatory commercial team BAL of our interact it and this patients, cartridge by pneumonia pneumonia in as we the equipped Clear diagnostic received LRT customer the several for any of the Unyvero from Chinese been we trials advantage Acuitas Unyvero the the with and applications Unyvero demands China first is and both to And here E-IVD the review of quarter Gene A release. for XXXX, United and first includes OpGen’s XXXX of based NMPA have AXX decision. FDA are is cleared submission ensure clearance soon commercial comprehensive due Curetis February regulatory has for to to and Panel earlier LRT priceless products, which that in potential IVD review Unyvero submissions from pneumonia Timelines Europe. pandemic. in are subsidiary FDA dossier for for as preparation Beijing continue Chinese its as an system for Excitingly, of market. system Chinese the the extended for the cartridge hospitalized COVID-XX received which as Curetis instrument NMPA. NMPA response the during cartridge, clinical Bio, interactive we review and Unyvero as in various marked

has updates BCB, getting Now by completed of We for first. our the market, registration cartridge of NMPA hope the that to as start to the or does approval of in point the launch however, But provide quarters on subject pneumonia for the NMPA this also in regulatory able timeline Unyvero time, Chinese guidance the not system IVD partner in commercial remains be commercialization to Chinese the approval and reviews. provide the their XXXX. subsequently process the coming specific plan any at

before, this Clear of deal ago. Beijing has commercial signed Bio the mentioned been and several was years the fully negotiated contract As with side

no deal So of to X.X China to the in of U.S. it made negotiate its reemphasize, about minimum rates. commercial final contains progress AXX and foreign commitments needs eight-year there anymore. XXX That million prices platform. the phases revenue excellent $XXX also current agreement development RQ adding in We’ve million cartridges period was an transfer OpGen to exchange at Unyvero current in and euro-dollar place cumulatively over absolutely the is in and in a already Unyvero to systems

with verification antibiotic system dialogue Flu all AXX testing put sites next Gene that should final antimicrobial-resistant for assets testing. platform, received in first OpGen we quarter already OpGen testing. a have specifications continued we and And into for opportunity New about the resistance of on second the XXXX, call partnering XX in around on during XXXX monographs. to been statewide. at B SARS-COV-X we had such of present announced so. begun RSV, several that It COVID-XX system. year sites the have the last detect, several the several Department Flu of Acuitas has assays of believe a AMR XXXX continued track, reopen. doing several and could to We the potential mentioned may platform one to partners AXX the established hold readily that And a the also of had infections the have We’ve products have such XXXX, our for and for today, and running in a expect due under including onto small be developed itself instrument potential a third validation with We that manage by of institutions several In we that series extension and actively middle for and Panel cartridges, healthcare quarter fourth the A State been partnership pandemic Earlier program quarters. quarter XXXX, with York our available previously

four the and today, New the We’ve City centers more isolates of XXXX. from that on Acuitas across volumes totaling testing of fourth hospitals significant up state York quarter tests XX XXXX Panel of testing quarter affiliated first networks are and the in running. and up AMR Gene seen ramp run the York New in than As into of

to significant be the discussing, and We’ll of during of bring next we’re dialogue broader attractive collaboration. slowed quarters. testing a to and confident think with beyond very revenue OpGen York XX, York New two $XXX,XXX $X.X expanded currently would State statewide a about had up extend year the New of Given forward XXXX. parts that our how testing on will the earlier the and with totaling commercial Department March active the million State extended that how upon the Department which COVID-XX also such in Health rollout program, extension XXXX, be end potentially more And to on a at path the third to in in on than terms year we’re two with the of and Health otherwise expand

to state the with New and of made York our version quarter Gene research current full Going we’re adopters OpGen that progress pleased use very being forward, year closing, results. of cleared product at the than the fourth early only rather we with priceless and Acuitas AMR used. In which also FDA look to become Panel our some sites

of as We leaders portfolio very have will products only resistance strong in further positioned an the remains drive combination exciting the our and Post company’s growing will believe in significant and entire momentum shareholder growth across which line market help our product portfolio. role implemented products, value. successfully we pending focus notable space. and antimicrobial the OpGen reinforced to decision and portfolio ensure our publication, becoming capabilities such well realignments the collaboration, one has the of towards grants, This revenue top with numerous industry prospects that peer awards, to core we’ve FDA us achieve is the business position by includes subsequent market pipeline reviewed and a clearance been bioinformatics switch in along AMR such IJI United clinical FDA and the States, milestones, eventual and additional future Acuitas Panel Unyvero regulatory of the price U.S. Gene clearances. with of trials UTI launch the and commercial submissions their as

for thank focus work their execution. wholeheartedly our of Company’s and employees globally to like OpGen all ethic, phenomenal would Group I Finally,

continued product tirelessly successfully the operator a like look we turn to the and to ahead new back to to combine Operator? the now achieve together. call past companies the As for our year we’ve many year. worked through exciting and forward questions. this to portfolios would will I I pandemic successes

Operator

you. Thank

We begin first will your the question Chen from state Wainwright. of session. Yi Instructions] now Our Please [Operator is H.C. question. question-and-answer

Unidentified Analyst

is commercially if approved the panel I this after projected revenue be was launch? AMR Gene would This and the classify behalf from for you [indiscernible] your of launch Chen. how guys. the what year Hi, could speaking test could wondering soon once Yi full you Panel

Oliver Schacht

Sure.

As I prepare. to continued have said, we

usually once truly in six number in order So of any typically take calling FDA get to a you weeks eight anywhere product, diagnostic weeks from to molecular launch. it’ll clearance

and we’ve Now that period best to can. tried as shorten we compress

collateral obviously produced the process. gene being maybe AMR trained, has manufactured done. the QC organizations marketing to clearance. clearance, is need have a and FDA several FDA on batches fix the sales have run have It’s label We been QC basically We be Acuitas product. Once we of the panel to product. It through our appropriate and and hold

Acuitas possibly as I the in RUO AMR various examples, over active couple for FDA a customers product. to mentioned cleared and the certainly run that them converting the dialogues We’re today of

Gene not be In that revenue, will we’re a panel would for terms broadest be first-in-class would We AMR It’s to you these first products. anticipate the kind the at a providing have FDA full of the cleared. year anticipate markers complex it’s have, once cleared, isolates are type typically, at first any point. Panel Acuitas Again, product. its going guidance and this to of of genetic specific we resistance antimicrobial

specific as But out hard the any down giving annuities $XXX product the any complicated this six XX comparables, it’s industry you per for to in that systems not a system, can period? potentially you thousand need at anything obviously, this look cycles couple attractive if the truly final uncommon we in hundred, makes instrument they months what’s system, lengthy and labeling we and And instrument try and to tests XX indication from hospital point even utilization being larger or given boils $XXX not see that’s How tests it you the how and network. a we systems out, will, gate funnel’s again, can to many any area the these month again, of way for from on annuity, at of But can that nine novel allow fairly per to we’re us or prepared year, several sales some to if because as So on FDA call, again, going system? to it. think it test. of that guidance, per run You’re are place? drive we’re ballpark very place you Again, at the looking somewhere if And given to claims on make. can. to a many to about in see the

Unidentified Analyst

success. and helpful. That’s continued much very Thanks we Thanks. All right. very support

Operator

of next Our from your question question. Group. Jacobs state is Edison Please Max

Max Jacobs

to after Thanks regard just to guys. deal, the the I approval? was China with wondering, like year for of what how revenues sorts in see taking first – can marketing Hi we my like question. expect

Oliver Schacht

previous original previously – Beijing being Clear with for of and years. was disclosed publicly if some back I’ll the the greatest look what’s contract actually, So at this again, five you disclosure that

five-year instrument initial up and a million revenue XXX that on systems. in then XXX have basically added that at and cumulated as added €XX the revenue. cumulative a were was would €XX it eight And And added period, seven million years approximately and that six, another been systems another a on During later to negotiated stage, minimum.

think in So if million dollar $XX six year terms linear. right €XX or it $XX term, fair be this million, going which so to about I say is to you not take U.S. is the that now. Over a million,

You’re each going through sort of Clearly, through – going to see you’re bulk growth going et goes two, of instrument see the you’re the utilization, you’ll then cetera. their account on. have phase in first cartridge the years, see three and as to one, an to in internal early pull following exponential placements, validation,

probably build up an €XX as at S-shaped if five-year approximation million, that going and you’re a you close little we adjust So million take stage. with come cumulative and can again, then number it provides $XX curve, to yourself as

Max Jacobs

question. opportunity what then can great. not based necessarily in helpful. you Okay, just was Can do That kind you on a – the And one, Columbia, is? ballpark? just something of revenue us on separate it’s you give that sort But of year think

Oliver Schacht

look XXX mean, years end, at low the if at I year. call a be at the could the X,XXX tests XXX, over that you anywhere high Sure. typical disclosed is let’s a what it, end to Unyvero systems, instrument we’ve XX from of minimum so three up but Again, system, a Unyvero running tests

United lower the XX%, ballpark, to to the somewhat in distributor $XXX You in the likely customer States. at which be customers towards to per revenue ballpark. likely industry, being look going test $XXX than again, the be our margin end going here end typical with in XX% in usually pricing, But that

our we transfer course through sale. as So generate of the OpGen price-based revenue

and – only, you diagnostic beyond names industry. annum. the into in at of course, initial deal You look looking sort markets. the annuity of they’re low expanding country, at for on figures, American basis. sense of figures ambitious the the ahead a arc brand an is six per is there instrument are per a in and This certainly, per Latin on five And you one. certainly Columbia number Columbia their of get some relationship, a high Columbia look They’re strategically, They’re additional if again – instrument from

hundred And the like review. was providing FDA regulatory coming – no initial a basically here, of weeks Leader it’s So interest tremendously technical is back It’s Event, the clinical the could news over from way in the trial, really documentation is level, go that Right at Opinion no to several the beyond paperwork and a a positive look focus couple urinary now, is blood done. us of not an there with The strategic participants of beginning CE cultures, Columbia, all five for at five areas, that Colombian there half, whole pneumonia, Mark We’ve the this five Key the feedback. years, least of good partnership submitted Mark get CE files – right well to each full And expecting blocks a the probably and implant XXXX infection, gambit Again, the market. then and we’re a remember, and tissue was through cartridges Unyvero second you then process. infections, season the there’s paper-based. clearance. They’re purely tract fall products. infections. much there in they Columbia documents, go and the taking pretty it’s launch the product portfolio system intra-abdominal disease can

Max Jacobs

much. so was Thank extremely That Great. helpful color. you

Oliver Schacht

out about years, you Vietnam, commitment three just same instruments, minimum a that you first if regulatory deal, is agreement, basically a for mean, in being example, additional Columbia And of process. the actually, as on this I which think we have cop deals, such prototypical

it’s always worth. So

expand drive to scope, clearly, to continue continue the top line. our We geographic

Max Jacobs

Those Thank Wonderful. all were my questions. you.

Operator

state Our your from Ben Haynor final question. Global Please Partners. question Alliance comes of

Ben Haynor

afternoon, questions the the and gentlemen. taking Good for progress. on congrats Thanks

covered be been test. know NMPA, you the only to have there’s hear But would So from like to lot heard researches any China. them. first you more But haven to from of heard it their you’re BCB, it I going a on any and on me, sounds expectations for anything launch possible of BCB not

or And there, handful that there if are I’m So it mistaken, for the installed in color not. hearing XX not there then the way I Any more I’m it sound you? doesn’t like question. think the

Oliver Schacht

Sure, sure.

and so you Unyvero early There’s very I’m dozen large all studies. even certainly their and with hospital. a been one a about Shanghai testing publication the regards of of yes, systems – Beijing. end Our at to platform adopters. number they friendship They’ve the regulatory of hospital over years couple them. strategy in deployed analytical RUO. taken number going has Unyvero clinical required sold speculate partner systems, Again, sense. Sino-Japanese had not largest and to last these the of of a have top on a the the application give a institution, through They’ve roughly some and systems the to pneumonia It’s of and

data. you NMPA Now specific a and by we that with active for very we and the ancillary do that know that I’ll certainly dialogue requests get way, in the got one through they’re example of specific we sense request documentation is a give advisers, Beijing of trial XXXX we regulatory in list data late any for their the ancillary partner fourth that and Clear quarter from our have. the NMPA

institutions FDA Now course, here of of U.S. name as Chicago we’ve and Beaumont, already reputable a but peer-reviewed been HPN European has the couple, them LRT Europe. like well all LRT both a number from institutions studies you Michigan, increasing trial publications, in the to investigator-initiated our data, of United in Northwestern and provided BAL data on States. journal of there and Karolinska our number in as Give and

and the China, a U.S. and I’ll having the from of FDA, quality of now They we likely all States questions, – going better But of is there compare the a dossier the documentation be not very take business So it NMPA as feedback, of diligence we if part everything know. too always the we’ve done the ask it’s so right is provided request, best of all FDA. for United believe par standpoint, salt. provided same with same from that I’ll And the with again, it dissimilar typically grain procedural and from on a have that of that decade, to data. NMPA level then you because to last they

days goodwill, days the when by past. relationship, guess, a I with So and little were just long bit get Guangxi those you with would

to enough enough and name the good we countries. get It’s European to approval, world. to believe in It’s United product we’ve good been there Health been we’ve again, in submitted everything Authority Malaysia get the into markets. of enough the Frankly, product good the another is States. everything Thailand been couple approved there. that It’s submitted So to get Singaporean

might body got focus I’ve Again, that on or to in to to either ancillary whatever it going need probably back. support that’s with Again, us they China. to has a boil analytical, in being installed are request foreign not be multiple specific And but remaining pneumonia data believe data systems. we data that, is evidence, to clinical based strong already data rates really of to getting product huge the generated or local going that. Incidence So clear it’s fundamentally improve questions on they’re to China. there really just down of Chinese generated

throughput a big shouldn’t So duration, be from that a and issue.

a have United We’re and week, partners. talking second-guess certainly language. our and the support to their States ready But FDA, time directly we’re every we speak hard now, to review enough to same we the right

same in We’re the country.

of we wasn’t after So sort – layers we everything we seal, was, the submitted months, we’re marginal I mean pre-warning heard confident was, signals I Chinese of out that three just a approval. there removed letter, without right? like or a there red from get that for all I NMPA we’re and are blue, the it’s it definitely anything couple arrived. a of frankly, here. direction, good haven’t the positively – in again, – Chinese But trending surprised that think when

we may there all but we’re any with doing make questions focus kind be, it So to all everything answering again, happen. of let’s on can certainly partners

Ben Haynor

the definitely And go, begin rearing the But kind sense on already you but train details BCP are, terms that at out that. Do sense. what about aspect of the the the – of does how are I have they Obviously, a quickly? sits do they kind makes That would moment? – of it they how of there. commercialization are, sales to thinking just appreciate personnel, get then, people? Or Okay. terms their of real gate

Oliver Schacht

across of they mean, organization they and – Hong clearly Kong I all decent-sized Yes. a there XX plus sort – provinces Taiwan.

sizable systems. So they’re They a have company. Unyvero had

any modern focus launch their and Now like technology China. pretty for cutting-edge in western initial much

provinces rural and XX to not to You’re go China. going

the go called cities, to to frankly, they’re And the AAA there as in China. than in there’s hospitals China of over and big again, is AAA more going in enough which, X,XXX You’re hospitals China.

hospitals. to would worked systems team over trained. Beijing, the of there The Shanghai, couple on last Again, major with years. of those has cities So anticipate other top-tier launch been fully some the again, multiple have they and installed I focus the

They’re their commercial their closely team team, marketing in our their technical working very So team. Europe. with team,

basis. a We continue them to meetings with on face-to-face very regular have

by So one They’ve was the of out in a point one for these Medical we’ve capacity through, has never manufacturing years. team. CEO Medical disappointed been of a almost professional Heraeus the invested It’s Heraeus business for year-over-year. basically very they’ve for The they’ve XX even by told grown data been guys. me, Beijing come additional And Heraeus. and exclusive I Heraeus distributor is years our been many the with relationship there, would ago. based Medical commercial Beijing Clear corporate other throw and this strategic partners, the on we’ve building Clear, referral

clearly we’re So excited.

I is working been excited far, So can say we’re all and with of end their they’ve be up the to holding them. bargain,

Ben Haynor

then that you balance on licensing color That’s thinking the great. better some the or just And have. of terms partnership I the appreciate strength drive about and of potential these agreements could to sheet,

also you Are balance Just of the posture you’re with restricted sheet, have already negotiating the folks to that increased seen interest? with? dealing changes

Oliver Schacht

would this are avenues I say simultaneously. corporate point, and mean all large several we of not aware partners multiple that I good conversations multiple ongoing the question. They’re parallel partnering with conversations, mean It’s really. I there again, all a at have we’re pursuing.

of large number I Ares – other and really away. just months but years, going hard diagnostics we’re the any bioinformatics, some whether sheet rock Genetics would That gone would look on partnerships I that we’re to at deal. industry. between to QIAGEN, – and has would have around certainly you and any going build focus or just or signing Sandoz of remains potential a for how at a strategically franchise be if say had so also the about algorithms. a at build Qs partner the say to place, taking ago, it’s be And players the simply in six that AI-powered a known our K this, look our while balance has looking

look, think I here. let’s say, really ability So be strategic to the

a royalty. too Let’s upfront, what in value we much upside, trade amount let’s the early to ultimate too the can on small and not together, too then is the downstream focus do at of the a prematurely product. also on and The relatively would value on of be much pittance going

any be in to that revenue product license a it’s potential So fee. going of royalty and upon

on So the this further That along ability partner, looking co-invest strategically certainly to us sure year some a commercially. the carve out covered quickest you R&D rather side at very for a that potentially two. strategic possible licensing are deal gives the we to may get drive with the there or R&D and different areas here ability going than to discuss just to make collaborations for next funding want

Ben Haynor

just And me. lastly Yes. sense. a That of then for makes lot

the Just to seems meaningfully wondering like establishes that extent the AI I look but to best response Ares like to something the well. people? more Genetics, mean as should from going more thought leadership kind that’s these kind what’s the you’ve industry investors then of And it response seems the of resonate that investors, there? been How the than of it publication. – that practices there kind that is gotten at

Oliver Schacht

Genetics at the of invited been again, leadership of AI but It certainly some side join, has invites. Genetics these, about be bioinformatics put And given JPIAMR, to the the the has on global roles Genetics another and there’s things. on talked both We Ares Ares consortium Ares map. to has large of

antibiotic extremely of predict with in of and is that’s only is a date, that true accuracy. company publication, the actually high first-mover To not susceptibility but ability demonstrating again, Genetics I is globally part. resistance, advantage, has to Ares antimicrobial where one So this predict would RSDB FDA multi-center levels the really the guidance lie. USP the Genetics a Ares only – That to the peer-reviewed

usual strain advantage forefront databases And Ares RSDB Pharmaceutical Siemens the Merck it’s first-mover at strain you that antibiotics to continue XX,XXX definitely sitting today their in combined XXX because, solution with with the the on stay at Genetics leadership We if take and from to with collaboration seen that. what clinical role on suspects are, inbound the of investing and from interest that goes looked the of of over and and asset, to in look collection, global got them next-gen leadership consortia this the top-tier requests phenotypically us keep a NGS the that its put see. those for at truly of and collection to against in players great, is is you of opportunities look which total. these So look into invite number course, sort require explore AI. But a at to sequence, out we’ve certainly microbiology, diagnostics us and to there at antibiotics, furthering next-generation industry U.S. centers who beyond a players pharmaceutical centers academic is hands, PCR as the goes it syndicates, isolates map, global the certainly in that got and which it’s and aren’t you to have good it’s will we’ve

Ben Haynor

it That’s Tim for are all me. great. progress. Congrats, and Oliver there That’s the

Oliver Schacht

All right.

Operator

today. we time now turn the the I Schacht all back That’s remarks. have closing will Mr. call for to

Oliver Schacht

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

Operator

lines today’s disconnect may your and you for time. you This at Thank this concludes conference, participation. your

OpGen (OPGN) 26 Mar 212020 Q4 Earnings call transcript