OPGN - Earnings call transcript Q2 2019

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Operator

Welcome to the OpGen Second Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode.

Following management's prepared remarks, they were hold ex-U.S. Q&A session.

As a reminder, this conference is being recorded today, August 7, 2019. participating call. for all you in today's Thank

results Before comments in by made company's from I or OpGen's would identify filings and management to encourage caution that like forward-looking the to that future operations during specific the Securities the contain the with statements we OpGen. review forward-looking I you begin, may and those events XX-K will forms cause regarding of this conference including, Commission, recent Exchange results to factors materially differ and described limitation, actual without most XX-Q, statements. which call

and Factors the of seek service to products include, but its successfully and and competitive for factors. by and hospitals obtain of may success timely on other product New and economic are and ability and regulatory effect demonstration commercialization existing its services the the successfully, its its with of regulatory project clearance to, offerings; healthcare that of company's new its complete York providers; rate commercialize affect and effectively efforts; not cost other results State; limited adoption the requirements business and

as after live XXXX. date as to this The is today, only time-sensitive by of the conference update call any law. of required or except revise The the events X, call the circumstances the of reflect information conference accurate August or company undertakes date obligation that contains content of no call, to statements this

CEO. over Evan I like would Jones, OpGen's the now Chairman and turn to to call

Evan Jones

update the will everyone, objectives financial quarter review progress and On And this call, Thank results, on we year. afternoon. for discuss business XXXX you, key thank recent us second joining the towards operator. you, provide an for our today's

XXXX. a updates June period revenue including million the New had to our XX include OpGen's health will first initiatives, the $X State submissions FDA in and completed X-month $X.X half ended and for discussion compared XX% initiative. year. York infectious We the Total our solid digital of to commercialization pipeline, disease planned product million increased Our on

continued priority of AMR Panel During on Acuitas Panel clearance antimicrobial market. resistance our May, seeking quarter, submission genes highest FDA Acuitas execute AMR product XXX(k) Gene for to Lighthouse novel In Software a the the OpGen we our and the detection second filed bring Gene bacterial to to in Acuitas isolates. of

are pleased with the review We and are is robust process progressing. the proud of we application, how

for Our we ongoing July, feedback been agency the dialogue with in information. additional formal requests to We has the are received and first agency encouraging. working their our address from

responses in We to anticipate data and the our review in will fall. early the first of to through the agency submission process technical we interactive our providing continue support through early provide August,

this line AMR for receiving we bacterial Panel use and Acuitas Assuming with would successfully for time to the supports the we fourth clearance anticipate responses, in isolates the our work FDA Gene quarter.

urine Concurrently, urine and pursuing we for software identification the from versus suspected of detection for the patients prediction urinary and Acuitas Acuitas and X Software. indication provide from FDA will -- for infections. follow-on pathogen resistance the patients accompanying Panel Gene The antibiotic Lighthouse are direct Urine submissions diligently tract AMR direct

In Gene AMR submission. support the FDA submission July, initiated Urine FDA we to the Panel for testing

of the submit quarter our fourth to late majority have the mid- trials We to the late sites the trial the and pacing in DNA clinical work. or subsequent expect third-party first in of the to XXXX submission We contract, depending XXX(k) X de we clinical and clinical during novo under complete sequencing the on work fall. quarter of plan

Microbe strong presented publications. to establish with that The under at through In transform scientific had OpGen's the view demonstrated that precision offering Acuitas was and this presentations pneumoniae, for strengthen the the a as In patient with phenotype Healthcare for that marketplace Geisinger. agreement E. the than data Gene pathogens medicine of that we most testing hours XX% coli presence addition AMR our ASM with event. greater that data the detection to peer-reviewed quantitative current and FDA antibiotic provides our Lighthouse Deaconess than Acuitas care and potential to Medical in in the AMR and greater Panel and the had tract cause Panel for in study, total urine predictions the a In at Gene with Acuitas premier Beth submissions, made culture the company and pathogen the data working the progress support Conference, Acuitas analyzed. Israel average Geisinger leader results June, the fundamentally presence we test with for collected urine from by tested specimens study versus Intermountain standard patients Center, days the XX% Data verification These over were for had clinical infections. care agreement industry's common klebsiella susceptibility XXX remnant an are X urinary urinary product to test has infections. tract semiquantitative X

to from Healthcare guide rapid to Center Beth used in use Panel and a as the Deaconess AMR the demonstrating Investigators data be antibiotic-resistant empiric diagnostic Israel from from OpGen, UTI early Medical with and potential Acuitas bacteria. of Gene antibiotic Intermountain presented collaborative a with Acuitas Lighthouse patients the study Software

settings Gene of that and OpGen be is the of frontline suggesting health by AMR turnaround Gene carbapenemas-producing analysis York State Health for State the an of the laboratory. as outbreak concordant Wadsworth data presented Lighthouse AMR one initiative. clinical that used Panel Acuitas can was for Department supports Panel organism key the outbreak in New finally, with And digital to tools but the a transmission Acuitas of use in sequencing, capabilities method This Acuitas Software whole the the genome WGS, detection. WGS reference New products was faster York the the Acuitas investigations comparing time, or and suite with

Health Department of fall to state infectious In medicine precision the healthcare connects ILUM and an collaboration develop digital of and our Health. health to with Health the Solutions announced we the disease Department institutions York the that XXXX, throughout Merck's New platform of State

ultimate and the Lighthouse X goal end of software to helping the and milestone Panel systems. ILÚM care integration customized of continues is of of the control establishing outcomes project antimicrobial advance second surveillance state-wide and and AMR anticipated Gene included support deployment we at in by Merck Software patients. systems the the health quarter. for development the of manage milestone of in The software The X Acuitas well, to Acuitas the to collaboration our acute project to The improve multidrug-resistant resistance this pathogens second achieved patient with

approval State the their Acuitas of validation Laboratory milestones RUO has AMR authorized by validation is the of while to achieve to regulatory testing Center, for Center conditional is Wadsworth or that Wadsworth with package parallel, the continued a DOH Wadsworth Panel the State Program, Acuitas In group. Evaluation the New CLEP, the Clinical the New York Gene project finalized test received York Conditional Health of approval Department use DOH. means and the review by

protocols, an Panel an reliability Center. the for considered important health Wadsworth which may step initiative, begin by of those will regard supports another and evaluation laboratories test. own approval accuracy next our which is testing. be to to system laboratories of AMR New received, the product the and the after the prospective extensive is This Gene York the their It Acuitas comes the step, validations complete With from designation, State is Wadsworth following

believe the quarters. received has the We funding after milestone and remaining in OpGen we significant next to discussions anticipate over X steps potential program year. years, now pilot $X future We initiative this in million have opportunity continue a there initial regarding project payments successful the begun from the the a next phase. receiving is

turn our discuss call our Chief Financial Dec, Tim results. over I'll the financial will Officer, to that, With now Tim? who

Tim Dec

million with Revenue second a XXXX I XX% The R&D and the the for expense to XXXX, common of $X.X Thank stockholders half quarter-over-quarter. Evan. the quarter on decrease for touch of second for was costs million quarter the in Operating On due reported attributable operating increase of financial G&A. The with expenses our loss slight compared second $X in quarter quarter first XXXX. net company you, the $XXX,XXX compared to lower second second to per share $X.XX of or XXXX. quarter of per million XXXX of attributable today's XXXX or represents $X.XX which of results. the was quarter $X.X loss net call, to million the million highlights of quarter will compared for second XXXX a and $X share were second of for of a $X.X stockholders common

loss of XXXX. This development the the first with the were for with million $X for of net was was Acuitas over a clinical for of due $X.X half $X.XX our period the use million primarily of or half million, per for Gene The with associated a or million work of first AMR per revenue compared same Total bacterial loss half XX% net of $X.X first to Panel for the million XXXX the of $X.X XXXX trial compared $X.X increase XXXX. share with Operating expenses first the million $X.XX $X.X was share half to increase isolates. compared XXXX.

cash balance Turning at and of of June. the We $X.X end our had cash sheet. to equivalents million

early Acuitas in XXXX. future are from on we we our AMR clearance, we FDA growth will revenue anticipate see revenue While Panel achieving line not beginning upon Gene guidance growth, our in that providing continued top

In New $X State $X.X the a million York the project the of milestone recognized total second of terms have of contract. achieved have and we initiative, million

to initiative Evan past as mentioned, we stage of with As a capacity development is in we opportunity involved there that believe contract. the larger for a OpGen move the significant the just get

for expect urine QX in and in our and In to R&D roughly starting of QX million on trials total, QX throughout submission expect be to this spent this spend of submission, completion we of clinical expect clinical year, spend the late trial R&D for we our the As prepare we we FDA year. $X.X increase. urine and our to next

our additions teams go-to-market strategically proper as time. and our of the plans, sales, we assembling will made These be our terms to we finalize looking are at manufacturing In to commercialization add strategy.

We strengthen and sheet are to by ways cash assessing balance position options. our strategic actively various considering

assessing our and We that combinations M&A will cash are other well partnerships, financial runway. business extend as actively transactions approaches as

exchange strategic OpGen a is for Nasdaq finally, stock retain in to trade to shares to order continue maximize our on major discussions. to and imperative our our for And it listing

Our continued of with a the Executing on before to able X to of strategic the us split this Nasdaq and stock meet move forward compliance with priorities. will company listing that requirements or minimum we stock on reverse price $X the subject our November regaining year. is ensure

laid critical shareholder Overall, the out everything continue to we'll and to year, in value. at are the to the we objectives of committed maximize do power we beginning our

With turn that, the back I'll call Evan. to

Evan Jones

Tim. you, Thank

we AMR products of health opportunities one testing infections, be commercial product clinical market applications. with health isolates segments: the support the and trials products. These into several gearing XXXX, Gene patients for of strategy Panel market up public our and Heading commercial full for tract we key suite for challenges. for of urine our isolates testing our of largest for address see public organizations, of bacterial products direct at address systems will research urinary review briefly testing The I'll Now launches. and novel testing, control a in health to [Indiscernible] infection attractive risk AMR launch

project include looking with in focus growth the anticipated during system to near-term the half see installations product isolate targets in and is later the currently the systems adopt testing this surveillance that laboratories them the bacterial We first Acuitas use. conjunction year. and New and The clearance the work has with supported to We isolate potential these XX have for platform U.S. includes isolate FDA the State further a health testing. for sites convert to both Acuitas Commercial to York health XXXX. public CRE urine with of routine growth company's segment

expect to number by XX increase fourth or to the this We quarter. more

conjunction Panel annually. is early includes The to we AMR testing of only days over million use research clearance, for In not patients to annually target States. trials. The aid currently for decision-making. Gene X to is broader use. United that FDA market expand for in segment the this tests be being could with pharmaceutical used The opportunity in indication market available for to the urine expect the antibiotic Acuitas product up UTI ultimately in and Panel AMR is the diagnostic X we It CRO is for use Gene for estimate care clinical million acute

and and we near the our a and marketing FDA support. support our organization organization, in of Gene we AMR from and sales in sales first leadership marketing the product both commercial we have X envision commercial terms will Panel, launch. we As our clearance to in initial it expand Currently, for adding professionals commercial to perspective direct

channel key have to lead products' further to is working to market utility of been expansion that establish documentation The we expand Additionally, the reach. milestone will Establishing a clearance our relationships needed through these to scientific partner plans. is priority adoption another increased clinical product. FDA our important support

financings will Washington, meet meeting October, and transactions. the continue company These investigators benefit capital sufficient In for our are and transactions we multiple our obtain we financing To IDWeek for other needs business at in present field. D.C., the major partnering to to a throughout potential appropriate alternatives, stockholders. operating strategic alternatives in agreements, include order meeting in actively and combination the M&A realizing considering commercialization,

our to listed to critical major exchange. for is for time, on to a continue this on trade During and it Tim shares as OpGen Nasdaq noted, remain

to minimum $X with price regaining listing continued is Our requirement. the subject compliance the bid company

actively us objectives are which needs. our compliance, will execute We on avenues to capital simultaneously and to regain meet pursuing allow strategic

have they as network in our are our strong as foundation and key success, support a We of and collaborations These provide hospitals established to well as public area. the a launch to strategic health relationships the industry robust players commercial products. uptake of

Given products a the bringing execute to we this commercial we these to successful well around world. rollout, above, are hospitals strategy more outlined positioned believe

AMR milestones to Looking the into York the Lighthouse FDA Panel complete the State systems in health as urine rapid for half of as products to using we organization. XXXX; will family of clearance of New clearance; antibiotics; launch Acuitas Gene for we Acuitas back rapid disease novo Acuitas in already milestones objectives demonstration launch with the antibiotic the second for Software validations to our phase commercial half recognizing our include: XXXX, evolve we FDA the closed infectious market clinical first as of project Initiative development to support bacterial obtaining and of deployment FDA program and molecular submissions the digital completing the business Gene isolates; filing software AMR sales prospective studies for informatics following of to frontline commercial and FDA de continue Upcoming a we Panel advance successfully to prediction activities a and resistance Panel testing and and FDA Acuitas and install to Gene testing springboard, accounts. commercializing America, in Urine expanding have clearance following continuing specimens support full AMR first where Colombia software product South customer research-use-only studies

we half this I'm have appreciate with to progress We come. momentum pleased the thank support, and you first your I'm generated and afternoon. in year, the of your time for about the the excited

are We now for ready Operator? questions.

Operator

Your question Instructions] of first [Operator Wainwright. comes you. Yi from Thank Chen H.C.

open. now Your line is

Unidentified Analyst

is This on Yi [Faizan] Chen. for

application was had to samples? panel plan I do next for the question first for urine The when you XXX(k) submit the

Evan Jones

Urine and remarks our Gene first in for Panel or quarter press the of submission in mentioned would FDA We AMR afternoon. the the the quarter file the XXXX. that release Good we fourth

Unidentified Analyst

about a then it When the follow-up. XXXX of isolates we terms approval just Okay. in if for can expect in -- that. revenue And what XXXX? obtains in potential for panel Thank you.Sorry bacterial

Evan Jones

expand tried A the to of in success stay goals majority to frankly, and the giving York say important State be question. revenue in customer systems very existing then healthcare away guidance. the United to convert We precise our that, accounts, that States. the We've to New our base from continue could can large are

It certainly the but So that outlook. we're all we'll optimistic year about achieve work potential occur in won't to goal. growth X,

Tim Dec

get guidance as It's bit point, be a we provide We'll that. little our just doing further along Yes. journey. but this to at early

Unidentified Analyst

all me. for That's Great. Thank you.

Operator

your Aegis And Weinstein much. from of so Capital. question you next comes Nathan Thank

open. Your line is now

Nathan Weinstein

potentially thinking X I Hey, Evan said think for about might you gear with sales have to and the how adding Acuitas and a now. Tim, you up many sales about thought at regards to add? you you need organization? And how people headcount, you're just being more might right commercial-stage products

Evan Jones

in the for joining calling call. thanks and Nathan,

think So the pretty talent that full include we to will work when in the a gamut some done. And about be organization. commercial you coverage, you both small our down be includes sizing the commercial person would expansion really which but team senior ramp, leadership the field then both guide initially, X that help sales as X of needs have It's mentioned, X revenues growing but technical additionally, in the to and then the as likely support, there the dictate. from to

Nathan Weinstein

if be thinking to U.S. potential partners partner look of your you be multiple that then terms enter that, and/or into you in geographies, partnerships, were a if could to you could just do abroad? bring with And foresee it products Okay.

Evan Jones

opportunities important the and we Having said that, focus internationally. are segments. different being see for opportunity potentially an partner There remains into to the definitely U.S. split us,

the market, similar I'll instance, terms have then which XX is in that just would be segment, offices public the Wadsworth and and health and is the is For the to CDC. hospital And the a segment pretty fee-for-service laboratories which you states physicians' are, or opportunity. laboratory labs there's urology, more. last say, of the attractive There

Nathan Weinstein

Okay. in you path you And to then guess, just you have at come opportunity market potential saw and the products market develop down niche, on you and same of, the market of meantime, another do new from view still that including the look larger the Acuitas? when this and when one in the this today of technologies guys, suite for may niche see you Acuitas the top-down started terms I

Evan Jones

I would say we see a larger opportunity.

indication because has of the in I most the urinary in York healthcare ones talking how become New rise was serious arena Times, about the ago, the month one a some UTI tract of kind an indication. pick of may issue have to coverage of the fair, you think about work, it Some the as that that early which our explode major had clinical would us we resistance there. led as be in today. that idea exists We the of it But to our had seen of to first seen no

expand think patients UTI So potentially to a year the address the resistance. that this about for rising UTIs million high-acuity beyond when testing you see more X could realistically, million we well of testing XX

Nathan Weinstein

these and the for is discussed but well as we've one have just products Obviously, on been one antifungal final antibacterial, me. in focused it area an mentioned interesting And you'd that past.

public testing could a into guys you health auris antifungal the regards those Candida to future? about with expand something talked as threat. susceptibility that pathogens the Is testing You in and

Evan Jones

be. It potentially a infection, there definitely test yeast and but in we test resistant to our which future. line, see today we've for a could We have begun product during could don't XXXX. for already FISH instance, in some auris, increase for Candida We the in fungi, is demand

Nathan Weinstein

my for taking Thanks question.

Operator

from your Alliance of you. Haynor Thank question And next Global. comes Ben

Your line open. is now

Ben Haynor

Good afternoon my guys. Thanks for taking questions.

kind remarks First going September not you the curious the fall and are referring fall earlier going in fall kind you to about be timing into say early on on Equinox? astronomical meteorological little I'm pedantic, would for bit the to of Zodiac FDA. with the in prepared in starting you of me, early or fall, anything, mentioned soothsayer might a This the or fall just back starting -- consulting but I'm forth be there. a

Evan Jones

new I'm were We feedback studies are don't we encouraged will we want question. the that are that believe not say you. that is from sure by I it the required. to that any parse that there carefully FDA. love for What I

the we and review in forward-thinking We for agency us. the soon a we agency, -- in of want as an established resubmit, some process interactive we very the been have as and that for that cooperative the data has recutting agency, There's to to the data that get will. are they polishing

mentioned in agreed ongoing information we'll I the our provide we've that So to the them basis. on next days, the response agency. be making to And first

along -- agency, their the of you previously have labeling by that'll review will as as ongoing. the pretty have by that quickly of the filing. towards what And will data, move could the phase. think the followed and we reviewed So all then all as could anticipate be be But then official data XXX(k) submitting the soon we finished been

Ben Haynor

Okay. That's very helpful.

discussions you the as sounds it had see you've So it, is so forward-thinking. that the far, like FDA

there. understand Is correct really the don't your showstoppers any to You way comments? that see out

Evan Jones

get It's of product careful -- -- it on other that discussions. complete are we're to like in I and know the we, doing very we're be inside would, we've And there, straightforward get agency because done. with we thinking detailed the from cooperative The but understandable we're ones hand, believe, to the agency, not been our the they that. have the see and to think to going And them, to work I to conversation be regulatory market. needs We questions can address. but very and

Ben Haynor

sense. me, think rather mentioned have guess this the plate have, knowing combinations, to sense than strategic there well. had Okay. be good mentions potential a those there what's sooner and some that's anything color partnerships, think of Is could cetera, And would the that -- needs you as your Or advancing makes capital on for gives That If you about alignments, that helpful. way I then et you've any that? I come at later? that past lastly moment something the you that in you

Tim Dec

active spend we time, together you lead on the we a in obviously, best way be put is, to certain is of that answer can and that to continue answer thoughts. the But way quite we think them short our So way the here that bit will I best in a and to active, I term. think I such remarks prepared would very we're

Operator

are to There turn will call at the currently time. now Mr. questions remarks. I closing back no Jones for this

Evan Jones

to that part our a step want the And Thank this commercial activity I of around beginning of products, you rebranding mention completed up the as our to very for we've everyone, much. company. afternoon. joining did you, thank

We've look website, on progress. updating things new of take of And very you much. see company's further a Thank gotten you good customers. progress at look feedback the as If you'll some from the forward it. you we proud look and to www.opgen.com, We're feel.

Tim Dec

Thank you.

Operator

so much. concludes today's conference This call. you Thank

now disconnect. may You

OpGen (OPGN) 10 Aug 192019 Q2 Earnings call transcript