ALIM - Earnings call transcript Q2 2021

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Operator

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences Second Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. this end be November of of hour approximately XX, replay the after the webcast call available will one XXXX. A call through to IR, now Gordon firm. would like turn call I to of company’s the over CORE Investor Relations the Scott ahead, sir. Please go

Scott Gordon

Good thank you Tom. conference in for and morning, you, participating today’s Thank call.

Alimera’s are and today Rick Chief Jones, Joining Phil and Officer. President from Financial me Eiswirth, leadership team Officer; Chief Executive

making or During expectations forward-looking results. management this be statements, Alimera’s performance will that for statements future operational including address call,

Forward-looking statements. statements other and factors that to differ may results involve risks cause materially actual from those

For please Today’s useful its performance. statements conference cautionary about Alimera non-GAAP more today. adjusted in in evaluating includes that information be a EBITDA, these refer to can call release financial risks, Alimera’s press measure the believes

consider in GAAP. with as You isolation in results additional for should information or prepared not substitute a accordance this

events the directly Alimera’s is of its a contains that financial accurate measure, this or For of time-sensitive of this reconciliation only see loss, table financial measure income The today, comparable information content GAAP press or XX, net release. reconciliation to located most call disclaims non-GAAP as any update please please earnings ahead. turn to law, in to XXXX. Eiswirth. by information over after Rick revise call. that circumstances Alimera Rick, any go now Except to publicly to August my pleasure occur obligation as reflect this or is required It the call

Rick Eiswirth

good morning and Scott, on call. you, everyone Thank the to

the First, you your earnings timing I for to with of patients to our want respect release. of thank all

complex Therapeutics, April The received Ocumension our resulted a $XX in the delays equity in books closing we stock a investment for rather for know, completed and and some we transaction accounting million you earlier $XX significant a payment, quarter. a with of in was this year. most Ocumension million transaction in for this As upfront warrant license which

the quarter, revenue license Ocumension transaction. consolidated in few we detail we Phil reporting As a revenue in more the results will released $XX.X the are during reported million provide including minutes. net this morning, our from regarding

In catch we and across physicians XX% needing average among offices, conducted and office and survey of saw about back to Although up is increased to across volume positive and recovered physicians DME of growing patients We is compared clear U.S. throughput. limited pandemic we to on demand quarter, several on practices effect trends the at market, growth, to this that significantly comparison believe our are pre-COVID levels. In short-staffing a seeing complications can result our are diabetes, in our levels. patient of patients due likely reduced July, continues to United the have there adverse XX the new markets. still depending by visits it learned retina personnel volumes seeing States States, patient protocols slowdown practices DME safeguard COVID-XX most second including multiple only United with of XXXX. pre-pandemic that the have business end-user the on we that patient in growth Despite QX practices XX% in to to due not the factors, volumes access an on in some to the

in – increase previous their Importantly, access to or of the calls over quarter. second are our as able in-person were increased across the our we signs U.S. XX% the seeing reps quarter across U.S, by

out have success, existing seeking new reps also while volume been U.S. Our our down. is user with accounts

of for addition quarter in ILUVIEN year, began. who the have highest added ILUVIEN was These the the we’ve of net in since of seven last We driven growth prescribing have in, signs the the XX% are during started second quarter by to seen recorded end-user the we XX%. level demand, pandemic available the which in International second six end-user accounts XXXX before growth In year. demand European at new of rest the segment, encouraging markets

the more which in Germany, this during to end-user we decline of For the The vaccination Despite which the resulted COVID for of in increase spike May markets exception the the and being comparison. were cases clinics sales rate recently demand ILUVIEN comparison low wave we a in COVID clarity, second a accurate demand. where to in encouraged substantial a record significant has in third end-user to not did were of in been across experience associated made for was as our quarter see a force, in a calculation arrival end-user of the in to with whole, quarter. prior challenges year, Germany available utilization, relatively the closed country Europe included

the Importantly, demand, believe in that now we our with is France, more the from performance for Spain we it Italy positive three we start obtained drive investments. placing reducing strategic transaction us are and pandemic. these to each time to inventories with Ocumension growth this partners investing seeing make their distributor shipments back consistent of We us behind these quarters. to Because the scheduled the seeing more before believe financing aggressively of the to for trends, our ILUVIEN orders distributor were and allows next

significant and disclosed, and maintain reduced at as previously made relationships pandemic base to result, of our promotional outset physicians employee of the the the we we expenditures. amount a a our As with decision the

spend voice. Our share of conservative has our during promotional weakened pandemic the

and this patients on We ILUVIEN hired and ILUVIEN, and of highlighted in-house challenges the Dyer we bring Dr. sensitive, this will need of of has I channels. development basis value medical giving from we quarter, the with retina injections to communicate anti-VEGFs associated initiative. a treating we the the as mean, help believe Given important other future our in communications to Specialist, physicians, and top duration that voice us that the specialist for drive our the numerous short the Retina keep initiatives. pandemic in our ahead believe COVID mind recurring frequent and In advocacy steroid and commercially success. opportunity intravitreal brand move need David to the second We the that to value to is investments marketing peer-to-peer that be of Chief

publications We and liaison will medical communication and level teams our boards advocates. with in science to frequency thought be advisory hoping our year the few continues we expanding papers patients discuss the next changes the of months study highlight some to over liaison of this review that develop Dr. an DAY of leader and with engaging our team to future over perspective that trial. PALADIN shape come globally increase screen the year the and also and and are that and as The of medical will remainder and to in patients access Dyer DAY benefits and study, and from to messaging discuss analysis build we group to seeing clinical This momentum ILUVIEN has Study, important could study. some the this implemented Study NEW to NEW the the enroll improved. last are eye

burden reduce U.S. channels, capacity, information. across of becoming we efficiency, motivated XX world certain such tremendous ILUVIEN’s We the Hospitals. are focused, demonstrate digitally digitally these treatments. that where educational extensive we will of include increase savvy, the XX new become have of in one-source treatment messages believe events patients significant pertinent other the educational redeveloping strained webinars healthcare more in the experience, and Physicians data costs the and markets clinic value the opportunity believe delivery high alleviate a and VA today, to In to short-acting to in also to system to hub database a the we translate have to will the collective hospitals screening As randomized the and by COVID phase. study clinical create further have as easy access a European steroid provide we our too have an targeted more additional

will on in DTP And We’re XXXX. physician-specific the we channels. U.S. also we increasing restarting direct-to-patient be digital or into advertising campaign move our as importantly,

recall, you campaign As a a may pilot key test markets few in select six-month XXXX. ran in a of we DTP

learned physician time lot those During engagement an a about, which saw that in were that and at which were we patient campaign increase in markets. elevated affected utilization We not. and channels

DTP our in longer the vision with injections. patients believe they see than maintaining with by further XX for Our an due with over they resulting the the three day lapse message of message Because up very to pandemic, the during to only ILUVIEN fewer retina worst patients consistent micro-dose communicate duration is is of excellent potential previous past of a treatment fewer and specialists a many were the patients heightened We presented every other experience vision period. injections that the time to maintaining core of of experienced. months vision promise of injections delivers short unable pandemic. with return, a with that did years, continuously the feeling patients message relevance resonated intravitreal well to When spend. Many in

We launch the will be launching few of preparing for this campaign the months before XXXX. in next over

be geographic months European five have six commercialized of little of units was the of in in pandemic. markets expansion seven In new critical the a ILUVIEN of promotional support year, XXXX, despite part to end strategy. continues because Our our the At been first a countries. this sold

we and late country. of uveitis XX disease uveitis. over in markets. as launched these an the we Further, could growth to anti-VEGF As we an believe expect launch for XX revenue of date, and are markets the to sell and partners. in of uveitis commercial in sell ILUVIEN oculo both given our uveitis We Remember, indication to XXXX up, We where indication posterior hope uveitis start therapies continue Germany our should for distributor and reimbursement this in for market. the has treat prevention of treatment pandemic. to UK increase our to been directly ILUVIEN right the anticipate in that only the in not where of all countries the remaining option countries receive we and open across recurrence we alternatives the leverage in be noninfectious and gold standard months And in the each pricing support through to the indication next before the the markets

exclusive specific the Phil in is for this for and initiate a the uveitis our we non-infectious diabetic the Tanner on Tanner available macular to for globally and a for where also ILUVIEN turn the edema, posterior with the ILUVIEN. commercially the call over countries for more Pharma uveitis. with and I’ll now treatment DME Just now of the Europe provider Group week, patients East is Middle in financial not Phil? program results for announced name-patient of detail quarter. product to partnership

Phil Jones

Rick, everyone. hello, Thanks, and

revenue, second of million net earlier. to that physicians quarter $X.X our $XX $X.X from XXX included of second all the end-user Rick pharmacies revenue XXXX, represents $XX was for the in approximately revenue in compared the demand XXXX. XXXX million in second million consolidated we generated and to XXXX. distributors of second XXXX. quarter units net was by units the purchased Ocumension the rose For which to reported $XX.X million from XX% during second the QX million reported of we quarter which quarter transaction in net XX% product in quarter XXX quarter million, revenue quarter up $XX.X revenue U.S. XXXX, compared second U.S. revenue approximately from that of in mentioned of reported and the license units product XXX% Consolidated up for the the

due purchases our our sold end-users. do of approximately we of previously the In demand distributors number our to end-user quarter in purchased As revenues not GAAP of second to have the timing same the XXXX, U.S. correlate by always specialty they shared, distributors. the units with

And $X.X order The the year. last two compared Knight facility substantial transaction. to COVID to was QX product million XXXX. of revenue access decrease license two, U.S. fewer distributor includes with International decrease the quarter to associated to purchased reported QX product was of by to partners was XXXX, While second One, in partially lack associated This in was down $X.X by cases $XX compared from healthcare XX% million to driven end-user restricted from of in sold approximately significant XXX% QX factors. for termination over due Canadian with who the agreement sell in our the revenue the period revenue of off million decrease revenue reduce with Therapeutics. Germany prior $X.X rise acceleration product segment continue revenue quarter same XXXX a in in year. International Ocumension XX% reported the to inventory during compared net the our approximately million our revenue The XXXX. for in compared revenue million for XXXX. to response pandemic. orders offset distributors the XXXX a distribution to in $X in in to than International units deferred demand inventory by in our QX the $XX.X in Net they acquired increased million

quarter includes to XX% QX certain Therapeutics. growth of the the Rick of France, net initiatives of $XXX,XXX the Total $X.X drive in markets mentioned, high revenue approximately sales again the challenges to end XXXX XXXX. XXXX. across Portugal, XXXX, Italy, was approximately distribution XXX for reported increase future of QX million in of spending in half We to $X.X of compared demand Ocumension With reported to expenses the million for license are million XXXX the XXX of the in QX an revenue termination with in on of quarter Across selling second of units XXXX. where quarter adjusted operating quarter second in $XX into the we Kingdom, product deferred we of the quarter United loss second and the a end-user the in second impact Germany. were positive user from EBITDA of and an XXXX Canadian access second despite $X in $X.X and from Knight European customers the XX% As EBITDA compared second transaction million of second in Adjusted Ireland, of were our and XXXX, agreement adjusted increase the to quarter. the million EBITDA in net a recovery with units associated new our Europe seven Spain Germany, demand in acceleration grew XXXX that increasing, XXXX,

for of For XXXX, Basic of approximately net quarter quarter to quarter net shares to the XXXX. equivalents XXXX. March On cash average income approximately net per second equivalents X.X to XXXX, cash X for million net that XX weighted second was the share on $X.XX share June approximately of we on reported shares we of approximately $X.X second diluted and average compares million loss the compared and $XX.X million loss million weighted $X.X of $X.X of had we compared cash the XX, income outstanding. and second and $X. of per This quarter a approximately for XXXX in million cash diluted XX, outstanding. on basic million reported

I’ll the Given back financial a strengthened sheet, remarks. for our of we recently closing our believe we Rick that going over balance are in strong the call position forward. growth to to business turn his fund

Rick Eiswirth

you, said. and the sales on Western in getting our granted in corporate along for other activities. and investing for rates focused remain up QX also to to on milestones, offers The Greater in ILUVIEN Ocumension million very agreement. that to potential back furnished sheet to We Pacific us Ocumension Phil receive developing as and for levels with license to improved equity by under The license infrastructure Thank sales-based growth future in $XX the rights Ocumension commercialized markup territory the have countries, pre-pandemic to significantly plus China product investment Phil. we a balance us our commercial we ‘s commercial license Ocumension agreement

operator we that result, on the the to As prior pandemic. plan the capital turn the U.S. we call do and strong and back question-and-answer business execute to begin session. the Europe, the core in With resources we to in believe the to that, our have a to over get we I’ll position to were

Operator

Alex comes ahead. Capital. Instructions] Nowak will first [Operator with Please Craig-Hallum the the And begin now We from go question-and-answer question session.

Alex Nowak

on end you of both could the and cadence in QX expand throughout for morning, QX? here quarter Delta How of are the is in month-to-month how everyone. end demand? Good starting Rick, playing OUS results things user tracking the hoping Great. just U.S. just things toward the and

Rick Eiswirth

Yes.

month, inconsistent. a lot flip and that you UK of like a Delta to We So, to U.S., We’ll the and a for on month in it’s great then country. tell the the have these lot the variability spikes and in inconsistency things variant is joining still next weak of the month-to-month in the strong thanks question, Alex, with us have and will today. it I depending month see a and tied that.

it right lot again there not is has there as that period and certain of for limited inconsistency things open jurisdictions just while – a a So is a now and of for where had access continue unfortunately we and I’m to There availability are close. just access been coming and we offices our than back to appears the share new the are of greater that to be and start. time really to seems accounts. maybe to utilization continue a stop at pleased adding patients slightly Overall,

we more come is think message So that the things volumes, get talked as news ILUVIEN that I just consistency the every continue value But consistently believe we’ll pandemic patient back. the day, looks to evolve. of working like highlighting and we about I you that see COVID it and read and change more with

Alex Nowak

Yes, understood. right or second me, – sitting half? is the shipped And you that’s think going you track demand demand end-user down how to much Do the U.S. outside in orders think closer inventory good of here and excuse mostly to end-user now? is is dropped do

Rick Eiswirth

that for deliveries should It get quarters. to three we next we much back should. in the as orders Yes, we on end-user hand in closer There demand. have are said

not a I some in just first to would us the some of be by third but in we’re match there’s some I say quarter. there yet, in year. the quarter, expect quite to probably perfect would quarter, quarter So next fourth fourth back

Alex Nowak

about just those of in Tanner of is the to the piece Group be deal? or lack reimbursement material relatively Is on And some like given Okay, can markets? to expand Just think going a that that’s that great. that? you how

Rick Eiswirth

Yes, hesitant you a and of approved at – available. that so would quote I interest I trade number to do ILUVIEN from I a we get is on that things yet want we to not that. lot I’m as like and tell see countries mean, where shows

We South trying Ocumension hear we it So, available product interest Even get from hear lot the where America. do yet, is not there. markets lot is a interest right? though of a Asian of to from

year, to have And $X there. Tanner think said there has out could up believe quickly to so million supply. how $X is a Group The that demand it ramps million we’ll do see. We that they we eventually can be but

Alex Nowak

then where investments across you infusion, number cash Understood. given to was the a you team you additional on make sales most the marketing mentioned But And with And and order hoping of different those. I on from – expanding cash, then Where just using pipeline wants that the clinical that the of marketing. regulatory rank kind from can plan from sales uveitis? do there side, any a a wisely just too? comment and side,

Rick Eiswirth

Yes.

the So I want be say and get be mind as peer-to-peer doctors three. that it’s really, the with to – with face-to-face the advocacy things to advocacy can and develop I team The to really would things, that going. my maybe and of quality on be doctors, environments are two would right? that discussion face-to-face more that going two of So more we engagement is top often

example, size the we are in increasing of U.S. Thought our Leader Liaison So team the for

similar Leader Thought that in as and and both well. we’re the is position Europe, adding MSLs to a U.S. Liaison in adding our in We’re Europe

do its in-depth slightly But and rules of compliance lot are Although TLL. doctors that format. those not relationship advisory because the getting with a professional the is a of that boards conversations focus different, the

next doctors York here dinner six last have types night. practices and the quite there Another is Dyer seven five I’m New had over of three I of myself planned team. or get these with our trying Dr. I leadership four the in to out a with of around senior bit and practices dinners weeks. different a more example those or with is, myself doctor of and country talk

are ILUVIEN – argument from and got the with practice associated and overcrowded operational to think systems would where make The they their we’ve have show ILUVIEN, we argument, can efficient both the with COVID there’s an they be things. great a think and of thing there for Europe in them a a from that there access cost great issues second more just standpoint do around market capacity from side also standpoint, specifically We uveitis. a but hospital

XXXX, part So to year. uveitis. we’ll big for the be the toward building rollout this as over rest of would a DTP story that’s that going third And be in thing we we out practices. then of that the be and that opportunity potential or many to But huge I a there this, doctor’s then through out and people think ILUVIEN demonstrate value with patients the agree really think there drive to to the is of effort patients

Alex Nowak

and far the new as great, just asset? that’s retinal as No, anything on pipeline

Rick Eiswirth

now. right Not now, right not

will We burner horizon, are on that to the on up but meetings we bit I more able dialog, and have nothing the a there started there out the be – right front little aggressively. things see as to looking we moment. nothing engage at say open some to do expect

Alex Nowak

Okay, Appreciate the update. Thanks. excellent.

Rick Eiswirth

Alex. you, Thank Absolutely.

Operator

next The Global Alliance comes James ahead. from with go Please Molloy Partners. question

James Molloy

questions. at thanks quote DAY for you taking a on the NEW XX guys, NEW I point? in trial. this had DAY the Did currently trial follow-up quick patients Hey, my

Rick Eiswirth

that’s Yes, right.

study now. about right in in the screening XX got the are There’s that phase. XX we’ve patients So

have hopeful in We as of been we’re year. of has we’d and are was up that and where will things see access starting to build Jim. the down, rest new come continue back. slower patient patients shown to not shut and improvement of that but like, an office the It’s July, our those bit the were have through restricted, some than seen the over that June people little volume that because that ramp access a some up Unfortunately, in

James Molloy

hitting Obviously, you anticipated. slower that much than pandemic the

course, a so? in, that’s over COVID, XXX next would variant, Delta in in of a year or piece a the XX With the year to year hard granted with but in expect anticipate it’s of the you XX you know like

Rick Eiswirth

that we’re certainly next a giving I recruit very the said, I so increase study. time not enrolled on it at XX to over lightly specific try enrollment this certainly that enrollment months. in The so. as naive that to or far year – exponentially that now. type will patient we’ve that mean, being the a challenge accelerate from up I’m had, hope criteria I companies it. been has is of will trying lot patients that’s of that treated very DME change very to A the patient – is times

on going just because to We’re not early to focus important that, it’s these do so think patients. we

going we’re patient be to So with it.

We’re doing the things positive we can XX do we to speed the seeing eight to are last it in over enrollment. up. weeks some that And signs

James Molloy

then say U.S. thank you it is there about doing with many important of to, Great, very excellent you. face-to-face leadership a And you you talked How and change showing yourself. currently? have And you’re sales. guys obviously and reps

Are variant or how With everyone, starting hitting to the that that working there? get at you able get face-to-face the Alimera? are is Delta to out you need people

Rick Eiswirth

Absolutely.

had some would reps. now. XX right one is in the our decided in about reps better. asked – reps had it got We’ve we’ve Florida. I COVID of number that got leave open access South is getting to just There turnover we the down in say you situation territory So we and

a first increase quarter in in XX% or mentioned, the quarter. face-to-face over I by there calls As the in-person reps was about calls second

some seeing definitely there. improvement we’re So

lanes. and greater a get quality and we than lunch in and in for have more up access to open entire practices more practice injection XX minutes a seeing get go and right, is to X where with lunch are learns, time the We

improve. seeing So there. I that continue improvements we’re hope to will definitely

As across is Alex, I lot of Delta the of variant. not and variability said there it’s a spikes U.S. to consistent though in because the

with up the seen We think frankly who of one in the that seen in and open biggest the the access And most Retina, here month tight Delta over last spike for over of or some you’ve so in pretty got is weeks, I Georgia. variant a last of couple been here Georgia. time. our customers things we’ve Georgia had

little be and it’s a more things think going have a for out how So see and we’ll to I now. stop bit months to of play couple those start of

James Molloy

comes the spend marketing versus versus a you linkage Looking revenues on. dream, Could little marketing there quarter-to-quarters on and decoupling about down the and the between coming sales the a on the spend little a and sales And bit and sales Is last XX% out couple goes spend? top? marketing of speak sales in to it versus questions you a sales bit lag talk up back the or? or when the up Can sales there the X%.

Rick Eiswirth

you comment do the to want Phil, on first? some provide

Phil Jones

first, talk Yes, I’ll Jim, spending. the – I’ll bit about a

are about had those interactions severe to our we aware and travel to bit last is the related into get if travel see months sales the out the we’ve engagement spending lockdowns that be able area, the in related rest travel If you that field and able look doctors. the you marketing between at we’re now XX see the And to for and more. what a as – XX the seeing occurs, field do we in and force are and an increase to to months

think of that results good I a we of that come advance interaction. will So to an hopefully is somewhat on based and see that’s that of what is increase just

James Molloy

any guidance And halfway You’re then last on through. question, any thoughts – XXXX? for

Rick Eiswirth

think don’t I so. Jim,

year. the not we the comfortable the trends that not for right but positive We’re call, a the real think of in in now. of spike are with doing to especially through rest went that guidance just that probably Delta now mean, providing from pointing right the comfortable activity I there’s we positive variant lot signs

James Molloy

the much. for Understood. Thank taking you Thank you so questions.

Rick Eiswirth

Jim. Thanks,

Operator

[Operator comes Instructions] Chen The with from question next H.C. Yi Wainwright. Please go ahead.

Yi Chen

revenue half do you international think this you exceed the the of growth? the In for year, growth my questions. U.S. to Thank second taking revenue

Rick Eiswirth

have to order distributor the expect say additional of come Yi, those that’s a that not, selling because back. do have the some and in see countries year of started we first great would product those question. half do probably we I

bit So I a Europe you level, for period little in sort as normalized of will – think time. back see a greater growth the come a to be Europe that of to get

Yi Chen

the completed the for timeframe? enrollment DAY think or Got it it. XXXX NEW expect trial, should the that And to to be enrollment with be XXXX would reasonable in the do you respect

Rick Eiswirth

We’re get working to certainly going to on be pushing enrolled and in strategies XXXX.

Yi Chen

second half this how we year, the should of at the look for And expenses? operating

Rick Eiswirth

So I saw quarter year course that be back bit think to that in fourth the XXXX the we will of levels little and of in you the of the potentially XXXX. increasing over a building

Yi Chen

you. Thank it. got Okay,

Rick Eiswirth

Yi. Thanks,

Operator

concludes This to to I remarks. for back conference closing now like would turn our session. any management the question-and-answer over

Rick Eiswirth

interest progress in today’s Great. on have you, call results. Thank Thank our Alimera sharing day. a wonderful conference forward for participating report on we to our you and quarter our for third and when next Sciences. call your look do quarterly all We

Operator

The conference today’s Thank presentation. has for you concluded. now attending

You now disconnect. may

Alimera Sciences (ALIM) 14 Aug 212021 Q2 Earnings call transcript