OPGN - Earnings call transcript Q1 2018

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Operator

Welcome to the OpGen First Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode.

Following management's prepared remarks, we will hold a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded Tuesday, May 8, 2018. I'd now like to turn the call over to Ms. Golodetz. Kim ma'am. ahead, go Please

Kim Golodetz

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

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

Evan Jones

and we and thank progress Kim, XXXX XXXX. remaining us This joining our afternoon financial you, results, objectives achieving an towards you, the business and provide for today. on our review quarter Thank months of will update for key everyone first plans

and and During pleased clinical isolates. progress Panel or We the infection classes Acuitas of Gene at RUO the directly our financial operational, only XX made The to we introduced and line that research expectations. studies. first verification we products that company. generally the nine and in Acuitas the encouraging antibiotics gene for convey with pathogens that the Results of with from use began development surveillance pharmaceutical the studies uX.XX were first quarter, test are bacterial results with test and our control urine purposes X resistance new are research during AMR detects targets from quarter

Following Administration discussion for Drug U.S. Panel protocols we weeks, trial recent clinical regulatory are XXX(k) in with our Food Gene the the submissions. and finalizing and strategy AMR

AMR and Products Acuitas of fourth Thermo commercialization agreements our second for PCR tests. We anticipate We real-time tests. PCR Real-Time these This Panel our during agreement continue incorporate filings a XXXX. making into entered Scientific’s technology Gene PCR the quarter global Fisher to of initial supply reagents. the under agreement foundation the an System TaqMan covered X important QuantStudio is include supply Real-Time in

Lighthouse analysis genomic interpret evaluators cloud-based in potential Acuitas and the Software Lighthouse predict antibiotic are Panel the resistance early results Gene manage results analytical RUO to we capabilities data. results presented We validation Software. antibiotic At test use month’s detecting of last of pathogens Congress of Acuitas sites are AMR multidrug-resistant OpGen's bioinformatic for targets. Acuitas We Diseases, and using resistance the The already QSX using Infectious installing that Clinical will customers. and European presented to laboratory Microbiology labs

successful & CDC in Beth organisms our to prestigious more Antibiotic the April, patients the usage OpGen which and is in Medical clinical and country in The the Lighthouse test is microbiology and FDA verify detailed will treatment meeting test. AMR Israel X Atlanta and the our will be American ongoing this Microbe Acuitas order evaluating units verification resistance Microbiology bacteremia at performance with genes conference impact conventional fungemia we significant the products. we detected in with provide centers diagnostic and testing reductions from with hospital the for For Society the accurately collaborations presented Isolate improvement of our of in in highlight Gene XX collaboration antibiotic want between after samples the Acuitas identification In Panel rapid Results and announced Software. intensive This a we This Boston Gene ranging study for care being Colombia. trial completion which showed June Bank, Resistance clinical in Lighthouse June from information. announced Panel several of one in I Center Deaconess survival clinically for in and receiving study prospective March ASM XXX%. collaboration health to with using of to XXXX agreement of Software AMR diagnostic rapid held tested XX% to new June. of

our contacts presence America. and work our have the and nurtured in there throughout South using are increase We we Colombia

we South to Colombia established in precision our a commercialize products quarter, America. During medicine broadly the more and subsidiary through

for product region with products, market our commercialization Our regulatory cleared subsequent in detection resistance the QuickFISH as and of into second offerings. process serve completing for FDA commencing expansion Colombia quarter. antibiotic Colombia's authorities Acuitas reference product Colombia registration will in and entry the anticipate the our sales with market further a

to cutting moment two increase in future. his review a our As the while pleased get revenue in tell Tim were we in invest new will and you significantly during quarter expenses

to capital operate July, coming equity a February, proceeds offering to a of with first discuss our offering to now million offering over Looking come growth products, for and part completed Dec, Chief ID the new from company. quarter last minimum effort revenues was price. with stock compliance our listing Tim? who forward successful our turn stockholders' Officer, Combined our our activities. The pathogen anticipated we January to to necessary of both have development net XXXX. incremental with as contracts, from In will will requirements $XX.X path revenue the call ongoing our Acuitas financial regain the public NASDAQ of rapid third-party from and from our the and into continued is international with revenue FISH-based products I proceeds now Tim results. we Financial public

Tim Dec

the our rapid quarter financial for quarter stable results. up our on first you, in quarter with XXXX to Total generate continues Product sales. Thank first sales line the QuickFISH as fourth consistent the highlights of quarter was I Evan. testing revenue touch XXXX. were the This of of $XXX,XXX, afternoon will quarter our $XXX,XXX first for of of some from XXXX

general million and $X.X of attributable in expenses first were first following the XXXX, of for of and net revenue expenses of XX%. quarter first loss We related for marketing $X.X in of first associated an to attributable year; in first from the per reflecting team million increase XXXX; quarter to $X the million, per favorably and the was also administrative from $X loss for made reduced of of million or This down compares XXXX a the saw expenses down contract. $X.XX quarter The a first with of stockholders net of quarter and from of million XXXX. sales in were $X.X Total or and decrease XXXX collaboration that the of million, $X.X common that in common operating reduction of million was R&D million expenses $X.X to our items: last with the sales XXXX. share. year-ago, down quarter share $X.X quarter the CDC $X.X marketing million compared we to stockholders This with XXXX, $XXX,XXX reported June cost a the $X.XX company due

of balance $XX.X million equivalents Turning XX, and cash XXXX. of our to had we March sheet, as cash

and one-half of as from raising million. as warrants, proceeds share in term mentioned, be warrant we much share a Each of of net in Evan common one sold $XX.X offering, of unit stock. XXXX, common and As public five-year proceeds $XX warrants date include could February a gross purchase Proceeds exercised, if stock million. the have one million $X from the issuance. to completed These

$X.X have million Company. ATM, capacity also under with We Cowen and our

shares. XXXX, raise After million X completed the also outstanding approximately of in equity We a to are one-for-twenty-five stock in reducing split approximately January from public our outstanding our million shares. X.X now million shares shares February, in down reverse shares XX

our we As cash. our our in began and of our last of of strategic realignment calls, operations June implementing discussed XXXX, uses reduce few cost structure on to a

going uX.XX $X.X XX% expenses this have quarter of And to operating We in EBITDA continuing and first our product second burn. of reduce on XXXX adjusted generated reducing than We further forward. from maintaining XXXX our and by achieve in quarter as more a has as initiatives. QuickFISH million cash revenue our reduction, roughly XXXX XXXX. that our which while an to and our to this maintain in had reduction well in per first burn, even the goal Our in These a with of $X.X investment R&D positive the quarterly actions half cash was quarter our significant adjusted half quarterly in $X.X reduction structure a million XX% impact half XX% XXXX. goal EBITDA second reduction, loss the our achieve million per of from roughly lines,

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

ATM uses our does investment any the As extend cash of first that not expect our facility. or Evan XXXX. to mentioned, non-dilutive half of strategic we include therefore available in current And

remainder year. the that, back growth, will continued optimistic value shareholder to along turn will the the Evan. call are of with I made future use We an through OpGen’s that of thoughtful support the funds investments improved we’ve With

Evan Jones

Tim. the from of key become on drug first quarter weeks, you, time that that well-positioned accomplishments is to a corporate We and combat resistant expand believe In remains, help infections. anticipated recent genomic to milestones. leader analysis I the and Thank using global informatics in and OpGen several the highlight will

prediction Gene last four detailed completed months, our to our the set products. includes of Software, and the pre-submissions AMR submissions. bar support The and clinical which uX.XX Over FDA technical through the high performance for test studies algorithms. our with from derived our for Acuitas data analytical working has the XXX(k) Acuitas FDA Agency pre-submission the reviews a for Lighthouse we've our regulatory has Panel been necessary process

product have We and and regarding content FDA the what will the face specific submissions to be through the dialogue multiple meetings labeling face studies, process. continuing of pre-submission

updates and submissions, clinical complexity through highlights continue this and of plan are with XXXX follows. work we trials as XXXX. the and Given into to FDA expect the the Several

be submission FDA the will first XXX(k) isolates is and traditional isolates. fourth third-party bacterial be first Our Merck of OpGen in surveillance Samples the laboratories. Panel also sources. and this from tested isolates quarter submitting work AMR be manageable a submission testing anticipate involves tested. a bacterial testing FDA Gene The XXX(k) bacterial this anticipated to of SMART fresh number for We will from hundreds patients of network XXXX. A other the to FDA by

will freshly an approximately XXX(k) a X,XXX This samples. collected submission include FDA the support estimate is previous this and clinical for trial A second indication. XXX Gene Our uX.XX from AMR samples. submission novo of Panel de will our to urine urine expansion be approximately

XXXX. patient process. be will and quarter the Panel. sequenced in AMR is data of item of microbiology Testing follow most samples We timing an could development the third with the work quarter tested to conjunction de with accrual into using will samples also submissions this analysis will gating testing approval submission by to DNA of are adjudication submission sample data increase anticipate both these All significant. a for larger and We tested in XXXX. the requirements in research complete will and and XXX(k) The novo that The fourth activities. anticipated be push for quarter the FDA in conventional be Gene expense first analysis specimen the these

submission. Software quarter compiled de XXX(k) a this be be we discussions XXXX. Timing the based some FDA, FDA lab for will Acuitas targeted submission for support to anticipate with the work additional the third third There will The on of software Lighthouse ongoing submission to this be first pathway. is novo

turn are overall still areas with be of FDA several collaborative. there While discussions the been the our important has resolved, to

approval our device FDA first that XXX(k) cautiously traditional the a are will With following predicate provide optimistic a timely FDA and pathway, review clearance we submission. the following

half revenue the Something we this the contributing are financial of cleared discussed our first to in product with plans XXXX. successful as process, have previously FDA

We continue pharmaceutical to work studies. base infection and customer for our for surveillance control offering, an initial to establish applications product RUO an

performing initiative XX have This help will goal test to health will test three of anticipated by AMR systems large launch prior build the believe these for institutions have clinical our or at four using of Our ECCMID and efforts. XX currently research installations product. the an additional three FDA remainder data year is be We the installations Panel end. to to of cleared quarter. the Gene to installed supportive second at base the for We presented commercial that the

to our Our develop control In QuickFISH Gaithersburg, for plan, income solutions June. initial the cleared in the middle Massachusetts. CDC support our facility we countries Woburn, in and stewardship anticipate during April, manufacturing smartphone-based progressing beginning Colombia infection is successfully we move contract product according from of deployment to clinical decision completed FDA low and Maryland anti-microbial to phase

XXXXX facility. the We approval a also successful completed Gaithersburg ISO for and inspection

proud activities. And strategic Gene OpGen the AMR team research we development, towards various progress put made important we by for progress We our encouraged and date tract to Panel the ROU urinary In these U.S. complicated with operations are and activities of infections. the are during quarter. during our with the working summary, solid into XXXX. effort objectives We financial our

test interpretation of that global first Software with OpGen this the will pathogens of family genomic the antibiotic Along products patient to results, help in crisis, our Acuitas series be has Our cUTI the help test three globally. improve potential the under the hours. identifying in antibiotic address outcomes or to is Lighthouse of resistant resistance expected

following clinical revenues quarter first large the Plan from of XXXX, the business. the to commercial AMR the the a Gene and to objectives Acuitas sale research advance QIAGEN to uX.XX OpGen for the XXX(k) in Advanced and as product development RUO demonstration third-party development. for hospitals phase to FDA support To of and project EZX support clinical and the into family system anti-microbial Colombia supply expect XL the business in We for application smartphone-based low molecular during remainder clinical additional use. CDC support Complete we and to seek countries. funding development solutions full Acuitas in middle-income To agreements contract transitions of Panel add for revenue-generating of X new the pharmaceutical continue commercial for in uX.XX control of information launch And under with To enter QuantStudio file our derive programs. infection Panel Acuitas fourth Gene cooperation to AMR organizations. the IVD its stewardship placements. will

maintain Finally, operating runway. cash we will cash reductions and overall cost burns extend

us an will of world-class fight against the role to building company a committed are at play infections. in OpGen important that All drug-resistant

for thank months. we and questions. over significant of the and evident of last few ready support in results your should you for investments these now the We afternoon. investments years vision the this become in coming have Operator, pursuit are this appreciate made time your We

Operator

our line Yi the from and Chen first Instructions] [Operator of question H.C. Wainwright. from is

Mitchell Spector

is Thank for the for going you two is standard today. question AMR Yi. Mitchell forward. Panel for hours question My within taking going there, the on our is Acuitas first detection be to Hi this the

Evan Jones

that correct. Yes, is

Mitchell Spector

Okay.

so today in the And to sorry. AMR uX.XX, filing for you samples many collected the be Panel have for Gene how XXX(k) tested the – for

Evan Jones

and for questions. Okay, thanks your

straightforward actual finalized as we IRB work samples as X,XXX be be what that but will being of. parallel And I There's the third-party There the think used XXX(k)'s. some will submission. and based as the that of of is is no in just – testing be sites are as There are a the there it we are described The in clinical Those and my FDA middle work, two of aware urines, testing. device prospective would isolates. will an prepare some the archives. on pathway predicate the may will is the summer prepared a speak. samples They who requirement mentioned perform through that remarks, I accomplished relatively pursuing OpGen that separate I isolates to clinical you we're. follow then As fresh are isolate XXX(k) of mentioned to would provided protocols bacterial testing. of testing

Mitchell Spector

go Okay, And ahead. sorry, you. then thank

Evan Jones

labeled just sites will those they we've to investigational of for tested is only. was our clinical the samples our testing are I going distributed say as sites we for RUL trials be from hundreds clinical product now the also studies use where the in and as verification it product. And describe when clinical IVD

Mitchell Spector

XXXX? thank Okay, then any you. do revenue And for have guidance you

Tim Dec

Yes. This is Tim.

revenue have guidance. provided We not

Mitchell Spector

guys. you, Thank Okay.

Operator

Enterprises. Howard Instructions] of our [Operator Horberg line from next from Horberg is the And question

Howard Horberg

guys. getting three hours in was are benefits to of to patient, results OpGen wondering Hi, two three to I what someone Merck. like under one the the the and

Evan Jones

Well, that. try [indiscernible]. you for I��ll And question your thank at crack take to a

from it workflow microbiology of take a also infection, tract days infection. can to First all but today, answer clinical a you several the get both the bloodstream urinary for know

to During documented there from well being, outcomes negative wrong whether infection be it's the your many time, worse. or antibiotic gets on are that

this bar call people two or class the two what So be to best it in positive significant guide, differentiates to It's would is best from for used are on based work test the what have having microbes. to important phenotypic hour initially companies will that therapy patients. the commercially, hours. trying patient impaired to industry that The on DNA OpGen getting growing because analysis on one in benefits do could be could testing the a the

pharma companies large with your supportive to with to we’re that would labs they very a can and for making testing, that test numbers and that other have what of to like Merck, And range. so process globally that of have antibiotic doing rapid see is been in help guide be that as certainly to regard pharma Merck modality And question guide these decision is we companies spoken business. to diffused What to. speaking

Howard Horberg

talking a life of Okay. With are regards the or to you decrease. timing death matter think to of or patients, be going are you what

Evan Jones

to I certainly some the is get instance for determine cases, life will or there’s other In met So as sitting a per hospitals, situations patients for hospital examples, that would day. an trying death this they a mortality patient a determine information money different XX% are certain resistant room, to of wrong couple antibiotic, the it’s emergency the $X,XXX us at in there where save this that infection, need they drug the have to have cases. view on average to to

Howard Horberg

No questions. Okay, thank more you.

Evan Jones

Thank you.

Operator

[Operator Instructions]

Evan Jones

If there thank are providing all this much. our you joining early afternoon our QX look Thank forward no further you I on and next questions to update in and conference call for very August. we

Operator

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

OpGen (OPGN) 8 May 182018 Q1 Earnings call transcript