OPGN - Earnings call transcript Q2 2018

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Operator

Welcome to the OpGen Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded August 2nd, 2018. I would now like to turn the call conference over to Kim Golodetz.

Kim Golodetz

This is Kim Golodetz with LHA. participating call. for all you in today's Thank

law. date today, the The Chairman and would of update obligation now to this Jones, products any is over OpGen's of adoption described efforts; in and results economic Before comments success factors of include, companies differ call XX-K by and August contains revise I and Xnd, made to I those information seek and the services OpGen's its the specific that for would and the to, commercialize clearance filings may other materially after the may successfully, and Company on call management to conference that live develop, competitive as or identify or as actual Securities or and care new encourage providers; but hospitals caution including, the by that like to its obtain and like events to without timely future offerings; limited operations of results rate regulatory XX-Q, existing forward-looking business during statements its to events The call, the XXXX. Exchange undertakes contain CEO. the that its conference of requirements affect of call with only cause results not statements which this and its by we required Company's of time-sensitive of OpGen. products review Factors forms circumstances content Evan forward-looking no I you ability regulatory begin, to to other accurate services and commercialization will regarding of cost-effectively turn statements. and factors. this Commission, from except date reflect the effect conference the are call the the health limitation, and

Evan Jones

to provide XXXX. months our our operational an business XXXX progress quarter, results key remaining achieved second XX% million. and and with from second and [Technical months to prior update the relative discuss million was achieving we quarter and year the towards to six for of our plans XX% for In financial and the of Difficulty] revenue the $X.X XX% Results year progressed will the the Company. This review financial to afternoon, we to year also increasing increased on decreasing Revenue loss for net $XXX,XXX XX% net objectives prior $X.X million. the loss $X.X

with AMR our Software. new clinical continued and Panel the AMR for lead We uX.XX. Gene of the regarding Acuitas We gene Lighthouse of clearance and Administration, protocols trial the rapid the reached and advance the Acuitas Drug pathways to test, regulatory tests development or agreement the FDA, panel the Food

file clinical first to in uX.XX the IVD our complete of to vitro isolates expected bacterial during is are fourth goal gene quarter and panel submission first XXX(k) diagnostic Our XXXX. an during for XXX(k) the trial submissions Subsequent Acuitas of follow XXXX. quarter AMR

the from test presented susceptibility Israel Acuitas Data CDC XX AMR with phenotypic These data remnant Microbiology Acuitas Deaconess year. conjunction antibiotics accuracy Difficulty]. this of the Intermountain the Research of [Technical and the conventional with data European earlier in we Healthcare Gram-negative Acuitas Center positive Software RUO predict by Microbe along Lighthouse presented June, the to resistance pathogens of introduction analysis positive presented isolates were Antibiotic were we FDA in samples Isolate in with panel testing antibody ongoing results urine predictions presented panel April's across Acuitas our followed predicting the XXX%. to compared gene This Use Software and the verification predict of with from XX% performance Infectious At gene encouraged uX.XX Resistance Lighthouse where are featured to and by Clinical then XXX the AMR Beth Only Congress the and highlighting clinical ASM studies for Bank. the antibiotic We Conference the Medical from Diseases XX ranged for four resistance. presentation, resistance of

Importantly, time tested rapid ASM for QuickFISH results rate prospective patients days. to and to and clinical test survival previously current the the treatment patients evaluating compared receiving the able that units we our were from the bacteremia our compared Colombia. presented for current standard-of-care. diagnostic Microbe, the impact with showed hospital our of three of application two with to we care using hours to product hours require the up intensive reduce the with fungemia in standards QuickFISH and test XX% results also two study for to in trial microbiology XX% The At just

we our As region. the there a previously subsidiary announced, formed Colombia to in throughout market and products

scientific starting technical August, a our strong to of as part pharmaceutical new our testing one beginning approval distribution commercial Colombian awaiting cleared, foundation for When nice panel as fall. with later commercial are the which In our and results, gene clinical are intend products. region is market the after from test, to accounts the of Leveraging panel of we we Colombia gene We in for see our regulatory AMR the authority AMR commercialization ultimately in anticipate trial. well. beginning Acuitas momentum this we QuickFISH

Officer, for We Chief results. large with begin of quarter contract the in discuss will in turn the financial contract contracts will testing XXXX. from who a final Revenue [Technical are these negations largest deployment to will Dec, now also over stages fourth and the Difficulty] call in I our our opportunities. Financial commercial multiple Tim

Tim Dec

second quarter the of financial was I'll for to Product our of to the contract. Collaboration of for performance. highlights quarter revenue second $XXX,XXX past was and some to for continued range the $XXX,XXX up for second sales quarter attributable quarters. in summarize year-to-date the CDC our report XXXX. the touch quarter of six Total of the $XXX,XXX revenue $XXX,XXX, second $XXX,XXX XXXX on of from the results afternoon, This approximately XXXX XX%

associated for increase. million following and We million net operating for to $X.XX $X.X half $X.X the attributable first organizations from expenses with were million, expenses into million XXXX the quarter million move expect stockholders first panel Total prior to and expenses common sale million of sales of growth for and $X.X million, of the net loss $X.X $X.XX million, items. $XXX,XXX the was were expenses $X.XX Total year, $X.X $X.X quarter $X.X was of six of from represents derive or G&A year of essentially $XXX,XXX loss months for and to expenses approximately of expenses slightly from compared for our down from $XX.X last an down $X.X million million second XX%. XX% to XXXX first costs second from year to sales months with the half million revenue flat The period. XXXX the changes general flat RUO per we of we beyond. down uX.XX were from clinical XXXX, hospitals loss compared per of XXXX. share, over compared was services R&D Acuitas prior six of as to operating million down of large Difficulty] share. prior $X.X quarter million, sold at were the made first XXXX AMR million, was for and reduced following million million approximately of or marketing and expenses XXXX $X.X share $XXX,XXX marketing of improvement year, were the Cost items. per [Technical with from our and or summer. the or reflecting the revenue the down first the year first for XXXX of sales for million the This $X.X in $X.X decrease of six $X.X gene marketing were reduction approximately $X.XX the administrative with second to $X net the and of compared XX% a XXXX. to stockholders months expenses per the for net primarily decrease six last $X.X reported due a for second $X XXXX common $X.X a ago a attributable team were Company R&D loss research from The products from of half the due The the share. The million, months Total and

XXXX. $X.X balance of to Turning $X.X XXst, cash our as June sheet, we with cash million million as had XXXX December of compared XXth, and equivalents of

the our evaluating to currently the coming are strategic strengthen sheet balance quarters. options We over

in cash. lower began XXXX As of our strategic our reduce our during a June first of to our realignment few implementing discussed of cost structure and calls, operations use we

of half expenses Our by goal XX% that forward. to XXXX structure maintain in second operating going cost reduce XX% and is the to

for million with last actions from $X.X These XXXX XXXX with the on the of achieved first first half the quarter cash roughly reduction XXXX. have positive million our reducing a have a per half of XXXX cash impact We burn, quarter had burn per goal this first and roughly of in compared year. our half XX% the for to $X.X

the We continue XXXX. to incrementally balance manage ways cash of burn our to throughout look for

and work to million be to clinical burn continue million submissions range. our the to our Given in FDA expect we $X.X $X.X trial quarterly

year. shareholder focus the future We in continued made with we have support of will investments turn the values that the back call that, With I'll the to improved OpGen's are remainder through along optimistic growth funds of Evan.

Evan Jones

that our panel Acuitas believe panel global clarified become for pathways milestones. the plan anticipated drug-resistant in highlight time the and FDA Through to we've on analysis the leader help gene gene and the using for regulatory remains, infections. Lighthouse positioned Q-sub several the clinical is genomic plans the a OpGen We will AMR and Acuitas I expand regulatory AMR combat that informatics and to corporate Software. well In uX.XX and process,

highlights ongoing will our to and details final the the process, and be subject of clearance final are here the key submissions While regulatory outcome towards our expectations. work

During for the clinical second and we July, quarter upcoming extensive completed to prepare work trials. the through

address incorporated test the DNA FDA. as both to ease-of-use improve and We raised changes by the have well to as robustness to points

contract investigational and August. testing testing ready now New kits to deployed analytical are begin sample validation IUO, anticipate is during under to in Outside are be trials. we and software clinical Internal or trial clinical our sites underway. use,

isolates. vitro two the least Merck The gene parallel. for bacterial will uX.XX sample any other the with approximately associated trial Our urine, AMR nine first to nucleic in with sites. and lung, XXX and and to primary Surveillance based sequences is submission provided indication clinical of sample pure gene XX from types. fresh be FDA type be XXX(k) on and SMART based be isolates bacterial in identification clinical We wounds blood, the anticipate resistance eight detection the of the class Testing obtained will in diagnostics infection isolates acids compilation sample testing of bacterial Clinical XX on sites. antimicrobial to will and colonies Study gene OpGen panel control with stock resistance submission will at for take a classes. at XXX(k) is antimicrobial beginning sequences six of in associated from anticipated completed antibiotic isolates testing weeks four The to -- be

DNA As multiplex submission. complex noted this previously, is a technical and highly testing

are As we an in quarter. FDA committed to submission complete the this organization, fourth

of risk we of and Escherichia to Pseudomonas with clinical trial at for indication in for UTI and be followed FDA agents testing line that involve two of sequences XXX FDA XXXX. as complexity, a begin urine. approximately complicated more in trial quarter tract The weeks classes. infections, fresh site de second be to fall has for semi-quantitation diagnosis XX aid specific an the samples The be will involve Coli, panel isolate testing we by this testing submission be the first of the associated and completed Klebsiella gene wind time will submission the Faecalis sites urine patients Mirabilis, trial. eight Aeruginosa AMR in nine Pneumoniae, of and The clinical XX as resistance the remain the with to samples. is optimistic down of for a approximately antimicrobial antibiotic in can urine Testing X,XXX gene or urinary but The XXX(k) novo six Enterococcus to anticipated to the contrived Proteus request class will eight UTI, will

days and incorporated and on isolates series predict clinical using AMR of it phenotypically submissions the panel quarters middle XXX(k) tests Lighthouse testing a from a assay will anticipate do commercialization are [Technical longer. to class quarter kind. basis. third The Following and clearance With the uX.XX Surveillance we of the decommission identified decision [Technical XX risks. and FDA substantive the statute days. to a will urine providing believe specific help in support have the anticipate clinical in clearance provide a classes Acuitas Difficulty] Acuitas XXXX species these submission of Acuitas clearance, a or will gene the XXXX the final resources be during novo take we process. of six timing CLIA stock estimates, from fourth representative The obtaining XXX quarter. of for the operations. XXXX in for efforts indication these potential laboratory AMR its and relational not will the on data XXX(k). from been initiative blinded samples software during Lighthouse further the request for be urine Difficulty] help the novo review a we tested globally will [Technical that the isolates FDA into have support believe of submission We collected be to clearances of projections. the lines FDA also and practice, for samples three novo Lighthouse Broadly, for the time panel series of we separate and the XXXX, De class identified resistance study. products. de anticipated predictive will incremental first complete our requires based Study the molecular In FDA for of and antibiotics. unblinded the five for regards frame. nine FDA submissions Acuitas the clearance on Based gene two FDA with for based The data gain to XXX contrived We will of submissions can time Software complicated models Merck's Difficulty] to stock a Software. review This during to mitigate De be on trial produced month The delay Software, to more be

three studies. worked to and RUO new in CDC large for Smartphone hospital product for broader have funded achieved Health We public decision performing development development in to business milestone applications the installations year institutions centers, for at base test control support establish is during part remain a area clinical Merck's underway clinical health currently hospital track the clinical using research RUO on we of have the project end. antibiotic six We in initial decision-making. additional third quarter. with by surveillance anticipate the testing health decision systems. and pharmaceutical customer of We support program unit based CROs ILUM infection installations of the Difficulty] and This We offering software laboratories; [Technical Colombia XX collaboration for at five with Solutions for

diagnostic to discussions as partner larger companies Our in outreach proceeding has vitro and planned. with been

Director is OpGen addition Dr. in our clinic world Simner a we We Parasitology She Bacteriology with an will all Simner. the provide we at continued very expanded quarter Institutions. the team we're and expert medical -- and affairs and is when Pathology, commercial, operations research the on field. detail progress to Medical In the Johns more development, of proud We advisory of Hopkins and fronts have summary, Patricia financial. announce. of specifics during made Professor board Associate respected the

on capitalize front position working have put Our hard work OpGen in we Company. the to strong are and the of in opportunities years a of large

XXX(k) and health maintain the business demonstration of as for burn revenue and decision uX.XX remainder the to reductions submission for based in clinical Acuitas control of middle cost support sale commercial for to AMR supply and funding of in panel development solutions agreements derive and quarter extend the hospitals studies advance and molecular to additional low our enter verification gene operating fourth new large contract following income product the Smartphone trials Difficulty] and cash stewardship the the development; and panel a CROs the business; its infection We phase [Technical of cash gene expect with overall transitions programs countries; the the and to AMR FDA practice the and OpGen XXXX file the during support complete development Acuitas XXXX development RUO clinical Acuitas public clinical laboratories; and for first under uX.XX seek and antimicrobial CDC into complete runway. for of family in to Colombia; rate isolates; in cooperation third-party continue from

and coming opportunity of and we of see in for support accomplished us proud work we've appreciate All afternoon. tremendous thank your during at XXXX the OpGen months time the into your and future. you We this are a the

questions. ready for We are now

Operator

the Your line first with from Yi Wainwright. H.C. Instructions] question of comes [Operator Chen

Yi Chen

Just to we the we as the the expect the expect of exactly as data the see filing to should additional gene data AMR Acuitas for panel see for far what filing registration what Lighthouse? and before clarify, before XXX(k) Acuitas

Evan Jones

studies are winter verification last since that clinical The have been nearing ongoing completion.

in coming into will at those expect published the meetings data We months. scientific be both presented and to XXXX. leading Those complete

publication forward, a described then study urine And sets Software. We as pivotal other looking I of of or submission, test patient you that our the to for Lighthouse submissions, also the part Acuitas our data prospective FDA data anticipated then have for and the the work. the isolates unblinding the data,

Yi Chen

from you the mid-XXXX, market half approval you the panel do second to intend around And Lighthouse obtain once both XXXX? starting and

Evan Jones

infection health. for already in panel Already starting and gene for use public indications. to approved are CROs control the we uptake the marketing We're of AMR that use see for in and the

our then for projections make order way expand be for want XXX(k), are building be foundation that financial and achieve to of to is then we further laying our we a growth to expand urine indications the able approval a we a we'll that and positive today And Lighthouse XXXX, phase. initiatives. been us as the get for predictions soon As it marketing our approval clear as isolates the enter able just and into for have for we'll the marketing to among customers in I step. enabling gain

Yi Chen

you color strategic could some additional you're regarding option finally, give the And considering? us

Evan Jones

will would sector when know. to vitro I get could as and us with let Yi, been the you ready appropriate for detail be have you we we channel really something feel companies in being discussions think good say don't of diagnostic it into in for in much have to announcement, there, partners we that except

Operator

presentation there any And proceed Instructions]. further [Operator with your Please remarks. closing are at or time. questions this no

Evan Jones

forward you conference Thank you a our seeing have to much. November look QX We in nice on evening. call and very

Operator

Ladies your and that concludes thank for you you please conference call gentlemen, We your line. today. disconnect participation and that your for ask

OpGen (OPGN) 5 Aug 182018 Q2 Earnings call transcript