KRMD - Earnings call transcript Q2 2021 | KORU Medical Systems, Inc.

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Operator

Greetings. And welcome to KORU Medical Systems Second Quarter 2021 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

As a reminder, this conference is being recorded. to with conference Hilmar like host, to now Jeffrey Hannah & would turn over the your I Group [ph]. Hannah. ahead, go Please

Unidentified Company Representative

Thank the results good Medical and of the of you, Earlier is copy Sherry KORU available release today, on XXXX. afternoon, A Systems website. the for everyone. financial press second company's quarter released [ph]

press today, are uncertainties, this release actual many expectations the and other in plans which call, our you, our regarding update press business SEC. and could forward-looking front We financial results we recent During no includes well as or results mentioned risks predictions and These events quarter. associated will our filings the based comments differ statements as to any our make of with listeners the commentary release including certain our most forward-looking due encourage on statements. of in on to matters. materially those obligation I as assume have to and

management which release of and During the filings press in our each our SEC, will measures financial call website. the with posted in our on are non-GAAP certain discuss

press the will including reconciliations with non-GAAP find the measures comparable those and measures, GAAP additional in measures these You filings. of disclosure our release regarding

additional filings Eastern please listening Since press releases has the on PM may call at SEC. most reference recent with then the recorded benefit For the of the the those related held Time. made was topics XXXX have X:XX to comments the approximately and replay, and discussed, this company's Wednesday, XX, company to August and

and Linda, go CEO call President the ahead. Chief Financial today Officer. Tharby, on please and Joining KORU's of Systems; KORU Medical Fisher, Linda Karen us is

Linda Tharby

and us thanks Good for Hannah. joining Thanks, afternoon, today. everyone,

a line it ending then review During in build Karen our results with a over remarks. top drug foundation to our discuss future at I I pharmaceutical depth today's will financials will for turn the strategy Medical. few increase KORU before closing candidates, bright our pipeline to and new strong quarterly continued accelerate second growth, of and call, quarter to more

to life and KORU Our home. solutions therapeutic in is use the quality delivery mission for drug Medical patient's the at through delivery quality of development improve high of

greater Freedom a life-improving market-leading patients treatment the more healthcare Ig the used convenience opportunity treatments in cleared is to the their With a today patients hospital at is cost therapy, there FDA or by Infusion great receiving XX% to Integrated lower infusion System than in on subcutaneous Ig Expanding clinic addressable immunoglobulin a space. Our both have of the of of $XXX home Ig these and self-infuse with potential share overall system. intravenously, the characterized drug in setting; volume that the we will total in Systems candidates our progress on capitalize of in leading areas. development market a position high Freedom than XX in call, million U.S. beyond over potential. I pipeline new Later also market Ig, in

million million for results to second quarter XXXX. in quarter; the reported of the our compared $X.X to of revenue Turning $X.X we second

two by second in one-time negatively events quarter revenue year-on-year Our impacted of growth XXXX. was the

due $X.X levels related million to sales COVID-XX. first was The to in increased inventory

revenues we encouraging high in reported pharmacy events, to was increased on we a Pharmaceuticals therapy our but last growth as trials both novel approximately data revenue the which channel, The our core our agreements and normalized basis, In domestic subcu-Ig franchise, feasibility of X%, business, Apellis an two saw in positive single data total two from companies. that X% clinical of saw sold second approximately in million versus we The quarter. of measure pharmaceutical sales indicators EMPAVELI. our these the in versus quarter-over-quarter our increase growth our into early $X.X key for grams - for approximately measuring the and in When year-on-year end-user market small with we quarters digit market stage one-time specialty sequential QX. last measure increase sales we experienced

The we This deal very very our KORU. market my research tenure been full with our meet we and the quarter have spent our in to high able with team knowledgeable time customers, a partners. our customers company. I've pharmacy the with majority specialty here a quarter retention engaged to has and I've a pharmaceutical market rate better company our have understand first a marks patient reputation great with and with and at of needs. of great patients, team,

to large new milestones plan. will executing the out and and efforts on focused required. have subcu-Ig our We the our strategy, resourcing In actions, the our Today be prepared share past opportunity, the the have we our plan. share evolution in on core quarter drug of I defining further we're pipeline, X-year focused we as and the team fall, our specific in both characterized building continued late business, will near-term the over and on

are future While execution, top have early to stages confident success the we still its laid accelerate we line and growth out therapy plan pipeline in a that drug of increased is candidates. roadmap for

increase penetration will Our in subcutaneous growth targeted Ig three strategy plan areas; in and first, focus therapy. commercial a core to

as accelerate is of market patients The million, areas The is this improving to drug in in plan the currently volume, KORU's quality leading approximately market operational less candidates and through increase subcu-Ig makes our States large in regulatory. and milliliters. pipeline foundation, $XXX in penetration subcu-Ig than XX XX% opportunity and position of our share our characterize we market. innovation, United which new subcu-Ig the therapy and addressable And business. up excellence increasing to focused the domestic focused above for growth short-term of overall Second, of and in at-home total core finally,

areas; focus go-to-market upon level. increasing at three in pharmacy presence accounts based data recently have our specialty targeted We first, purchased the

IVIg convenience the outcomes patient. subcu-Ig on of than Second based patients upon economics, patient healthcare XX% overall to is for converting and the the improved greater

is System as therapy an area patient ensure to easy make we as gain as of new simple services starts, at-home value-added the third the and share to possible. process onboarding increasing The Freedom

Over the out will we scale. them at accounts be services launching the next in select these quarters, before few rolling

also new partnership focused our in expanding are expected completed QX on an distribution Germany. in by We with presence Europe,

meets The order to for candidates, the as requirements; a complete second clinical of Freedom these requirements. today of companies leadership. to high modularity are with the profile has System our the pipeline phase approved trials on market dosing that candidates strategy the product XX subcu pharmaceutical new drug pharmaceutical is drug define increasing milliliters; has where safety regulatory an span which platform effective seeking In focused we their all of volume Freedom over

high past currently This quarter, phase includes volume target with candidates of that the on pipeline cardiology, these in endocrinology. pipeline across over drugs and of hematology a identified to Over XX the market. oncology, and X handful X immunology, are clinical majority we have a trials

feasibility have We and and therapies core five small scale targeted new developments. both, business new clinical discussions agreements for a across and drug in committed SCIg geographic seven our expansion, reformulation

Pump anticipate year. three for of the Freedom this by also end new the on indications calendar FDA We clearances

area operational foundation third on company; focus Our excellence, biggest is of the focus innovation. the regulatory. investment of building The for focus and and on innovation, area quality and is the

on and we understand Over patient the of the comfort will and KORU on to we near-term done new use. and attention our experience several quarters system, we with term, focus patient Longer last have research better will ease the technologies focus market partnerships.

and points. Our reducing underway, X.X an between to expected percentage strategy our the overall outsourcing being our initiative first already operational is stage cost position and focused excellence on with overall costs reduce X.X

impact is area talent. see tier building deep patient XXXX. of that to recruitment devices. President announce and that our of to in pleased Chief Given focus is delayed of the in Regulatory X quality Director lead competitive of Technology Class for of building backgrounds with out also top for with regulatory starts in both, the partners. Sales we've team final market both a a this competency COVID U.S. the volume, Vice we active Underlying our Regulatory a hired these VP expect We're a Quality and pharmaceutical executive the on and impact regulated Officer. will and of to The initiatives advantage part of with strategy early to We're

Before volume greater early focused infusions high turning I reiterate to a expanding few of manner. identified the The is plan. have large line is implementing Medical subcutaneous want growth a pipeline millions a million year. designed to pharmaceutical increasing in stages drug KORU our the to a potential points. safe total for market Karen, position over in addressable and with in solid leader per penetration subcu-Ig a candidates. Plan and the with top $XXX spend than a of call is strategic market while our financial begin in delivering We're therapy new pipeline of market increase resources to we potential,

second of turn call towards half XXXX, will look to financial with results. look over As to our now we we our updating executing I to you and the Karen discipline. review plan the forward

Karen Fisher

driven XXXX International for market believe patient period the included of recovery Sequential resulting due impacted X.X afternoon, revenues. from pharmacy inventory to were last prior points, in of negatively XX.X% XXXX, quarter. measures the by to from growth year novel during pandemic comparisons operating non-recurring for for increased the were Total XXXX high percentage decrease XX% channel we sales bill in indicating margin year-over-year sales to of therapy novel a of sales quarter Total large quarter year, which was million expenses Both good domestic $X.X in overall totaling [ph], second second the everyone. therapy. XXXX, the and $X.X increased of increase sales starts in unfavorable to for of second uncertainty sales, X% fees X%, for single the sales difficult net million, our Gross litigation new net second grew from resulting core million SCIg compared domestic by Linda and the a one-time a including Thanks, end-user quarter XXXX the quarter volumes in and events $X.X X% absorption. XXXX million. lower quarter market trials two growth therapy of same in was of $X.X the decrease second year. and last the quarter million QX $X.X aggregate in and of specialty due from which primarily million growth $X.X digits,

to Excluding same testing strategy diluted the development million, $X.XX Net per the the and XXXX basis, negative areas consulting or $X.XX and a in and research, second our second adjusted for share, fees, On second spent $X.XX of than from $X.X per including with and non-GAAP same commercialization, research of support also the the primarily XXXX. negative a initiatives. $X.X diluted the expenses fees, was XXXX. of the XXXX, focused Non-GAAP loss XXXX. our in litigation in regulatory second market grew compared was related adjusted for to quarter period of for for of $XXX,XXX quarter of strategic million quarter a earnings period EBITDA share quarter XXXX lower loss was unchanged loss

sheet, to cash, million second we quarter of Turning the XXXX at to million end our balance ended compared $XX.X of the in year. $XX.X with the

to December source. to inventory turn efforts million back to XXXX Our XX, Linda. secondary manufacturing due I'll position our to XXXX June transition over at at to XX, grew $X.X our million now it $X.X

Linda Tharby

Thanks, Karen.

growth subcutaneous for to in Medical. home the believe very due the bright turned we Before the of simplicity, at to we Ig that sales the or on begin above KORU and future Q&A, Based underlying corner therapy to call our We're over Freedom we safety to for market subcu-Ig rate. operator reiterate published and and data, the use expect sales I market the want grow is leader reliability turning Infusion accelerate, therapy System. have

and plan overall subcu-Ig to accelerate Q&A. addition, penetration over operator increased continue to back therapy our excited focused top line I'll call growth for pipeline now our our to turn innovation In growth. pharmaceutical our the on value shareholders. bringing We're strategic and driving customers, patients execution focused the increasing will of and

Operator

Piper Sandler. question Thank Instructions] proceed. first Matt Hi, Our with Please you. from is O'Brian [Operator

Unidentified Analyst

on on quarter. the for questions for [ph] congrats Carine the and is Matt. this Hi, taking Thanks

earnings So delta on other and variants; this starting cases off topic especially with the rise, it's COVID been and a with hot season. pretty

how year? thoughts of the the if curious will just how you - of these Just don't on for your share the you but here how you how some all on expectations and COVID know impacted internal outlook may perform has impact this and uncertainties? market, your versus the may remainder guide factoring your in We perform this market assumptions

Linda Tharby

Yes.

X%, And rates same the we're back year-to-date; we about modeling quarter which versus at two, delta would say about would the I vaccination X% about overall variant. we're the performed as So, I the half. was impacts market that expect of overall, overall, in impact looking thought in that the

Unidentified Analyst

touched your that's think on more distribution along little little reimbursement? and we Awesome, can thank a from you to you. should expand Europe, bit the a just And then And geographies going initiatives on years? you with bit these in how coming contributions about respect over how

Linda Tharby

by last the has start for larger focus quarter our saying in to and the U.S. market, been of in upfront accelerating going our on the I'm opportunity So, pipeline really here the on pharma. majority

hundred And the we in Europe two dollars narrowed the have a focused of of largest stocking really good and stages is thousand year However, end agreement we're made terms expect a the the of opportunity. of work France. progress final markets, we've Germany, in the the couple in done should to-date signing distributor, them. to in by Germany with we

Unidentified Analyst

you. thank year? XX% went one that run quarter. for margin, Is I the we of last just about us, rate base a And to off up for margins. to how And half? Gross back then, we think when Great, on then this believe should XX% to range? of in back gross margin Or expect line we that remainder about that the bump should that should the

Linda Tharby

to provided through So range. being the back of are to in that so agreements XX% XXXX; will getting we discussed would the XXXX earlier kick end of anticipate we XX% referenced about think in XX% by the volume the year And in part outsourcing earlier, range. the early then, that the the

Unidentified Analyst

you. Thank

Operator

proceed. Our Nowak Please is with next from Alex Capital Group. Craig-Hallum question

Alex Nowak

quantify seven Good everyone. agreements where these thanks pipeline. key trials? And feasibility? ultimately market the the the five the opportunity Linda, all into written in details pump the the be deals then, expected Great. by on is during afternoon, for pump year-end? also the Are on three during seeking commercialization? And to you is KORU expand have you the protocol approval the around clinical Can can signed; you FDA key

Linda Tharby

Yes.

SCIg are new in A) have of are - or with the for commercial agreements Two that would yes, pump be those - they we the the that beyond five classes, geographic imagine in and and there opportunities of the indications, either with trials. in really opportunity So, the then, the then there but respiratory field. expansion therapies. other expanded as with reformulation are some signed today; would can't that be KORU with in or three expand would new are another today opportunities; either, I used therapy you Apellis,

Alex Nowak

understood. Okay,

Linda Tharby

I them. into we're make system we've we would see directly other for clinical we're and to working application to The what a a is where on-market we particular meaning, to are call there can that earlier-stage stage need trials go opportunity, at either our customization early or an stage seven with an feasibility; defined

Alex Nowak

of you market? like maybe is seeing requires some it Got newer also drug high it. enough not you're influence subcu-Ig the But That come plasmin venture market seems of expanded directly how KORU onto the too. drugs can makes that subcu-Ig, penetration. sense, can enough penetration decreased or which talk [ph] It helpful. On to having

directly how just influence right? on So, expand KORU that can penetration,

Linda Tharby

Yes.

So, our I are of of increase shows, pharmacies presence is going class switch. then I specialty that talked you've help; working to to drugs that data primarily think trying think with and what about with but our into focus coming pieces new there at group will is KOL all, really heavily on make a rely first overall certainly which three to in the

base; pools we're us are subcu, and this today that basis. them on with working on of today to to trial several and are identify a try so with working go going start convert patient could that that we're patient to IV So,

exists have today, papers several there. the first data So outcomes; clinical shows data of we out all that published patient improved

then versus healthcare system; XX% home. over obvious a hospital Second difference is, has patients. in the - And outcomes is, finally study that the the overall for in shows cost the six to period a done month improved difference United costs

biggest partners. in of we'll all naturally written our will that do with years. don't working - the clinical at But work we practice with obviously, our conjunction market the challenge pharmacy physician then pharma for alone overtime, tools in the think we think see partners, turning specialty those and get space, prescribers there. see because But don't in have is us with we improvement several our can commercial change the need the IVs our with activities level, we farmer we know, of in So and in working this the conjunction drugs overall to partners; certainly, you

Alex Nowak

the question, you just just pumps; R&D more do obviously some makes regards pipeline, you what last I would line joined System the Freedom on you had go to also sorts Okay, System, other you've pump Freedom of here? ago, that a sort And maybe And [ph] company the just of devices. but months maybe of want then a sense. - the do How time study with Freedom on the to you think devices features could or is lacking? on patch to what couple guess, into add the expand how

Linda Tharby

Yes.

So bit have X. there the about it's first, talk little stage talk strategy; a I'll of clearly phase I'll on and the just then pump one focus we I'll today. about focused

call comfort patient and are said, the detail, pump, going stage. of smaller. I not to pump that identified overall that XX So help patients first getting convenience more to convenience; get the the the would either to that's on difference of train X, to comfort XX, I into that I therapy. and meaningful make phase clearly, minor And or size but the as I'm focused we we've these on make that can patient would with in say nurses Most and improvements what the deal

or the what to do pump we to we signal been can do as that set. the infusion electronics talked our patent look at obviously, either in give what an using or caregiver on-body about, terms we the delivered. third then, to say, do our stage, phase is, pump, that something is of And add has you off-body in portfolio an portfolio smaller pump a Second

see So, a pharmaceutical next critical course the commercialize today. kick we see you of I know, the that innovation six think over And of all to targets with this lot months. is of up you'll

Alex Nowak

All right, understood. Appreciate the Thanks. update.

Operator

our have reached We end question-and-answer of the session.

does conclude So conference. today's this

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

KORU Medical Systems (KRMD) 12 Aug 212021 Q2 Earnings call transcript