ALIM - Earnings call transcript Q1 2021

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Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to Alimera Sciences' First Quarter Fiscal Year 2021 Financial Results and Corporate Update Conference Call. [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 by a playback-purposes. A webcast replay of the call will be available approximately 1 hour after the end of the call through May 13, 2021. to call like to now would turn over the Mr. I company's of firm. CORE Gordon Investor IR, Scott the Relations Please go ahead, sir.

Scott Gordon

Good morning call. conference in participating and thank you for today's

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

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

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

today, performance. and recently adjusted in the EBITDA, described last useful filed risks, these Alimera's particularly includes please it. financial non-GAAP to in cautionary about be XX-K measure Alimera's that factors Form X-K most Alimera's statements reports press release information the more a believes For and periodic call the refer its Today's Form SEC on evaluating Form conference can risk XX-Q, filed evening, in with

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

Rick Eiswirth

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

in we the would early first presence of February. on the both indicated of of dual headwinds seasonality as and conference fourth our quarter be was in With typical continued challenging it quarter call our part the early in business the year the the COVID-XX,

of the over showed picked and of due insurance higher-priced returned year, ILUVIEN our In fourth hospital quarter rebound however, growth U.S. for markets. budgets' generally course re-established the seasonality our the markets. the and are U.S. reset European as as typical again That quarter. plans most as up also demand the end-user to is QX in seasonal case seen our levels across in first of than product particular, the was we've this deductibles end demand during quarter reads by the month-over-month First March a lower demand and quarter

Our by patients and postponing remain certain the business impacted is skipping in still and as of conditions. are pandemic parts visits lockdown Europe

to upon current global As our that occur full seen business believe a quarter. of we the the trends we return we've half the recovery second based in result, in expect the don't recently, until growth this year. to overall will we But

to growth Importantly, the navigated challenge including and while the our in ILUVIEN adding or through COVID-XX agreements. new license additional we markets and continue initiatives of distribution we key on executing longer-term of manage pandemic, launches the are residual

expansion outside and strategy and our segment U.S. a Our priority. key leverageable the gain profitable share market International remains is to

separate month, most of Ocumension retinal into develop entered rights implant to for intravitreal macular other As branded you know, payments. own In payment million a to company and license million ophthalmology $XX label. can $XX upfront up milestone agreement Therapeutics, and earlier diseases commercialize China-based we its Pacific potentially an we ILUVIEN countries we exclusive this Western China and exchange, a to diabetic and receive under sales-based our edema in to received and license

infusion X-year create $XX we also million shares us received right $XX common approved to in territories. to licensed our transfer commercial us product transaction up for manufacturer to And warrant is Ocumension goods additional streams. and capture a balance Additionally, offer the supply milestone our transaction. in stock launched our Simultaneous aggregate price a unique we commercial Ocumension. a and million solely treatment non-dilutive opportunity financing under and from to licensing in purchase the the of focused strengthens the equity Ocumension future agreement Ocumension provides we'll the supply exclusive future diseases. and million made sheet and to retinal payments another to potential us company cash Anticipated giving significantly the global the will value Ocumension additional be strategy funding once the from on from warrant product and agreed-upon Ocumension transaction, and for this to revenue investment Ocumension we X for provides an pursue The received

other diabetes very ILUVIEN technology a are Ocumension region. partner is that issue as Asian patients make pleased We diagnosed and where major with can a our and in to in the DME difference to have China markets real

near -- uveitis the both the region XXXX, pandemic. second distribution we we agreement Nordic during Denmark signed commercialized distribution recently throughout the saw Denmark, where as agreement In uveitis. a Norway, additional X that approval region. and Sweden, has pursue strategies posterior can of execute Nordic posterior Although DME pricing may the term we the during of in provide not and with for the half Finland indications Ocumension the revenue quarter first expect the to X and both in to announced This they in and both distribution we the to of ILUVIEN publication ILUVIEN for Finland, of for DME region, and be have countries XXXX. the expansion the drive on marketing end-user in revenues for partner relationship Denmark the ILUVIEN and XXXX, years our ILUVIEN in Prime demand while commercially approval continued covers first all In in Nordic

achieved posterior covered recently announced reimbursement we prevention of Scotland, of of insurers, reimbursement for We for which in eye work Netherlands under noninfectious XX% In DME. the hospitals plans. quarter, And in and the Health ILUVIEN lives are affecting relapse for Luxembourg's three Ministry ILUVIEN uveitis with the noninfectious earlier both posterior private together Recently, represent of for for approved largest ILUVIEN approximately the launch Pharma French reimbursement Ireland, in partner the indications continuing the in approved to Ireland, its the of into our to ILUVIEN expand private in recurrent we region. Horus Benelux in segment uveitis. the

of in the we uveitis year our Czech with posterior work October continuing partner sales distribution Italy, partners currently for Meritus Our year. are to additionally, in is ILUVIEN last to Austria in Spain, And Republic. distribution in indication reimbursement approval achieve the France of and commenced awaiting reimbursement Medical and this

contribution open believe As provide this significant that up, Europe against back growth a in our we the indication sales will to future.

only reduced clinical from sites evaluating environment. a enrollment We are changes rest that our reduction from results significant year. remember in current naive the the This near-naive position yet for DAY pandemic next our edema. a disease head-to-head visits advance with ILUVIEN to anti-VEGF important DAY Enrollment month recurrence, $X.X a therapy patients which utilized some achieve fewer treat revenue and phase. the support and target and the against seeing globally. in experience standard ILUVIEN controlled, facilities would the formidable has patients easier of macular outcome. to continue NEW standard opportunity NEW general also the care storage and to And in to Study patient treatment to and as greater study in sites confidence NEW up results enrollment, It in therapy In these Currently, additional give prior and study the eyes protocol successful randomized, of of in the new the diabetic real-world to an to billion introduce frequency, this the care order are we current to we is identify reduced well to population. to to comparative an been approved better first can accelerate for patient us expect the Study clinical DAY XX and we of changes Study DAY as several the an the who significantly multicenter to screening patients enroll effort make patients. the for XX,XXX NEW by affected positive to treatment design speed of a DAY that NEW Alimera. X in in our is is of randomized we have to has demonstrate damaged provide not adversely as We care and competitor the control, now over compared trials study that retinal it a believe over corticosteroid designed disease trial, the standard been

both focused before can we experience remain approved, number our COVID-XX the we all both sales ILUVIEN which For of three the in ILUVIEN ILUVIEN and organically markets, international which pandemic. core launched we our on the by confident #X, includes are frequency enrollment. This reimbursed, pandemic territories expanding remain of restoring physicians XXXX, partners. which patient of the Study we and #X, We distribution us. grow while DAY on to remain and the increasing in our rates goals NEW business indication noninfectious we on driving the the challenges, the do resources in Absent number is using our through growth and macular management organization we uveitis our performance sales of direct uptake and believe the done of continues, our territories. financial and well. ILUVIEN's have advancing existing focused with edema And #X, posterior diabetic new approval

will significantly utilization and have flows transaction, us our financial review call around with to quarter. Ocumension to growth results world. physician the capacity ILUVIEN drive Phil our more I'll the And which offices flexibility patient the strengthened With who increased sheet balance over returned we the gives as for that, turn in

Phil Jones

Thanks, Rick, hello and everyone.

from XXXX. versus first comparison XXXX first XX% $XX.X to decline XX% was first XXXX. During the XXX $X.X XXXX approximately patient's the compared XX% almost retinal of offices. the million This our compared first the which the XXXX, in was performance decrease $XX.X for reflects U.S. the the end-user net revenue XXX to distributors down reported period. in revenue of a of continued XXXX, The the due purchased $X.X demand first and the million million to approximately in quarter return pre-pandemic on of environment. quarter COVID-XX pharmacies quarter to all quarter consolidated was of represents to our units to of the of by first primarily for was current quarter ability COVID-XX in XXXX million net of physicians of approximately from ongoing impact units quarter the units U.S. to down

impact timing approximately distributors. correlate due XXXX, of As Alimera's of the we in have sold users. the U.S. than end-user U.S., year. revenue The the with XXXX. purchases million the This purchased always first our to our is for high they Net the our to million demand $X.X reported XX% fewer to over quarter was of of distributor by our approximately than to demand, the approximately the and In first the shared, last $X.X of decrease GAAP markets distributors do represents quarter. end U.S. specialty reporting course previously revenues not Consistent for GAAP International both in demand on same unusually quarter and with segment international units as actually it direct markets. for U.S. demand and our revenue $XXX,XXX end-user the more our XX% compares difference we're end-user direct from quarter. segment due period improved COVID-XX both decreased in distributor This the

However, of engagement in $X.X reported COVID-XX a to currently, loss with demand X% of overall loss $X.X slow reported million on first of quarter $XX.X million $X.XX operating quarters share a holding million diluted desire operating the $X.XX operating all more EBITDA of The XXXX. inventory a approximately equivalents return and million reported $X.X an dollars of approximately compared This distribution increase the drive approximately December X.X quarter approximately the were to higher million of are diluted first partners we the XXXX, XXXX. net QX XX, Basic approximately QX levels to of we EBITDA in XXXX, international to a over approximately QX cash equivalents shares million quarter average of average weighted outstanding. net outstanding. million adjusted compared first more shares cash XXXX, quarter expenses approximately on In net in of of reported in our X XXXX in prior XXXX. loss compared loss March million had to basic cash compares expense anticipation positive $X.X in share of of the loss we represented impacting Total physicians $XX.X normal of and first million $XX.X associated first in reduction to to in our adjusted and net activities. of a for compared to in of per that the XX, XXXX. $X.X for XXXX quarter XXXX. weighted We -- was the million and on base cash per XXXX On with

transactions cash Ocumension cash $XX million announced we license the As received Rick the in mentioned earlier, we by and increased early equity for from April. equivalents our cash and that

we result, going forward. strong position that we a a As financial are in believe

that operator to call We that, for of also million forgiven. received I'll loan confirmation call the from was turn our to our the completely lender And $X.X open Operator? PPP questions. over the up with

Operator

first Craig-Hallum Instructions] from [Operator The Alex comes of question Capital. Nowak

Alex Nowak

of a into a you April, the U.S. in just are seeing Can O-U.S.? what the pleased versus you're month-to-month, how trend you then seeing and April? compare just in us Are April, that continuing specifically at breakdown are that with that in recovery does you give month-over-month retinal clinics you seeing

Rick Eiswirth

some I weeks say Alex, some mean would We've in had I good and still had we've ones. remains April, tough inconsistent. it

Christmas, to slowdown it in have more at the me feels a of bit aggressively holiday little it taken holiday a time. experienced we that and Back over like Easter people did. think breaks I

a generally and saw the would that's of we But continue week. sales the consistent Easter markets, the a holiday. slowdown pretty all say little over the absent I to daily So Easter bit improve across

Alex Nowak

And don't high I bit draw but still out as mentioned U.S. is to inventory feel is as channel, inventory in was the here outside inventory or high sitting in there, it QX speaking then it you in QX? a the down just do see the some there

Rick Eiswirth

one it's Yeah, of We our good mean which it's picking course beginning saw -- the draw I quarter over down up in some. France, sales is the some definitely, to of in to we've seen said. of see pick well. sales as up of we pockets largest in up But Spain. start We've pop to as those continue some markets countries shutdowns distributor

So end demand see think end-user year. certainly, countries. do those be we of of to longer, going in inconsistent in little the they bleeding but down the it's of inventory at I to continue for some a they are that bit improvements Overall, all held

Alex Nowak

backlog with when starts either could anti-VEGFs demand that or guess there the need patients and that I a you come a clinic as clinics, these pent-up get are benefit back? they to is reopen, ILUVIEN rental speak hearing about patients of ultimately or to

Rick Eiswirth

I Yeah, think so.

access over much that the are be our good April. doing think clinics in quarter -- good a and face-to-face with in open continues fact, improved physicians we're pretty and more I to the the much, steadily

because patients some that we those I of seeing coming. is quarter. physicians, out just a we that better we demand. bit get treat waiting to But and our on slower that had with come because been underestimated, X of think as dinner the I we losing think get days their the challenges we didn't and mentioned that physician they bit the that vaccine. the back, want talked planned really happening pent-up of are were have a frankly, And getting in queue they have vaccine patients I diabetic that's they're specifically to this do something little spot to the February and the a chance to patients ago to call didn't take foresee a of quite

of we've through the they're when got patients back fight that of is the anti-VEGF, right. doing to is this challenges of seeing after they're huge I anti-VEGF think habit volume quickly very to one going

we've got that. So to time more more get face to break and to through try

breaking to the get we've the So I deal settling and into got to with backlog, habits that. back think trying of of old they're some to sort

Alex Nowak

over you up Just expect bring aggressively? that world operating to P&L, that if on look go helps the XXXX now more Specifically, here you capital. Ocumension would at in expenses your expect additional deal, Do some obviously to or the you the to any force? you'd you invest out there. really primary a is capital? like going it R&D, more And it have studies it thoughts target, is building is So sales the bigger more real areas the are be what

Rick Eiswirth

that that a we as always we like are to think that, Alex, company. a at but a even underfunded and things is was ILUVIEN give great one felt it's small now. of hard specifics we've taking question from look hard day do on one It's right the

it's more in going force, there. invest And to tell evaluating peer-to-peer air half out increased open try but bit know what not that bit as things team revenue little we the higher are year probably more ways faster in to level be, don't the a various around exactly can of to balance ways drive cover you sales the on the up. probably so that more the more I'll a conversation we level, get sales support going a advocacy second cushion science with that's to medical it's for I sheet, like advocacy conversation at having little

talk something we'll third about second that, the the as prepared into So be quarter. probably move end at to we're quarter looking we

Alex Nowak

then just last And question.

Just the handful remember I of in current of last back in was a the U.K. hospitals really to penetration uveitis and what uveitis the within Germany. only is If call, Europe?

but Europe within within Denmark You where mentioned in the remarks, opportunities also U.K. Germany? prepared near-term and and are then expanding the

Rick Eiswirth

Yes.

getting my for once most difference. we uveitis, of big and make there pricing be the to and the would we So think pandemic. successful low-penetration than get reimbursement. approval in opportunities think during more and we launch going the things uveitis and launches know most uptake we rest Italy, been are It's will those say the the in in new to up that it's uptake would and so for any can able hospitals open biggest you in the our Germany have expectation been markets. it's and of see been into we I rapid only would U.K., be has the to hospitals European Europe, see more our a us convert hard I get will of because believe, still as launched Spain, and Candidly, X, Big those reimbursement be we French the France

Operator

of Wainwright. Yi question H.C. next Chen comes Our from

Yi Chen

has on provided is the question quickly first any can get we ILUVIEN market? on Ocumension My how Asian guidance

Rick Eiswirth

this X be Yeah. time, the will locally have to years point right X at that. Yi, how looking they're to because in current at expecting to to expectation trials do some it that clinical and they run we're about is

is that do would they believe the ways we is a faster -- regular will they look the Chinese However, on with and to continue say there FDA I situation for get basis. to evolving

there some we're that probably it's upside be X And this to may suggesting point, or so but going to be X at years.

Yi Chen

point complete this the believe can still you XXXX? do at NEW in trial DAY early And enrollment

Rick Eiswirth

goal will access some the speed hope some but that the of date, because time to now improve speed the up changes things of next our need make we it's on that of of with new up. to this changes been Based certain That's to but lack we or a these these pace. we point are we to patients, we so. plan some hope We'll challenging over where month

Operator

The next Global of Molloy Instructions] from [Operator Partners. James comes question Alliance

James Molloy

question on of for quick are you Rick, are chunk deals the I working market on, additional -- see, out additional geographies? the of deal that cash. sort Are that excellent there Ocumension guys you had a bringing what the good there in type on Ocumension

Rick Eiswirth

nothing on would in maybe territories that's And ILUVIEN, believe our out part even we forward. eminent the strategy Indian the bit Russian some have of the of there's certainly there key big access be is South Jim, to potentially already interested markets, So, market geographic there but where a data we are a expansion trying quite and we do America. that going

but -- are places for do because patients. patient think looking point very So is we anything it always valuable at to for eminent other ILUVIEN don't product available make a have we this

James Molloy

that Europe on disaster the thoughts what's with impact aware -- latest over bleeds into India, been on COVID So all? going that the at you are that may how if Any there. absolute

Rick Eiswirth

Jim. point, No. this at Not

James Molloy

looks suggested And on down here year almost guided you stock second any a like? first then quarter the you in as XX%. And what in quarter guys the have year-to-date teeth was guys tripled that the guidance the here

-- thoughts what be looking may been your XXXX So XXXX may on Any like. message I think has excellent.

Rick Eiswirth

think say think growth quarter definitely Jim, don't we said be normal mid-to-high last the it's to but we'll the of But and well. be growth. point. at as this don't second I some to to typically year I teens be back always growth, over back hard have teens that quite growth mid-to-high I to sequential we'll some but you'll think able see

James Molloy

question line hopefully in posted and are through last OpEx and would the you And sales of in guys up sales marketing, marketing you kick be expect in sales G&A, these going and a Okay. the as maybe rest the the year. numbers R&D, little the what maybe of kind and the

Phil Jones

are is salespeople previously things bit travel, bring more, are being as you doctors more Yeah, We of hampered the are a of doing QX bit along able we things get a Jim. I traveling, number we spending behind out levels. back-up were engagement opening That think well more XXXX, XXXX more up. and overall that little lot kind the -- correct. will to putting money know. be so a of with little do And our People to the of lines the would that we see what QX that would of that

James Molloy

looking question I question hard on I then guess last that potential at million any of coming typically -- I the in question-answer the forma ask It's are on opportunities course. $XX attractive? now But or books acquisitions to the with pro calls. And know

Rick Eiswirth

looking. So, those thing Jim, frankly, transaction Ocumension out does bigger would one us to some give is at dry powder table The conversations, I the there it right. it seat have about some a we're say of the in

parties it to currency we've are serious past in that have conversation. just with there out to that So allows there us little I that the more think in bank, frankly a talked the

sheet look to little we more with So the plan aggressively a bit balance strengthened.

Operator

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

Rick Eiswirth

early for in all our very our Alimera. and when look We thank quarter in forward call August. conference or at wonderful call day. much we and continued progress to on and have you results today's that Thank a of quarterly Thank and you your sharing be late report second July to all do for we participating next you, our expect interest

Operator

attending presentation. is concluded. Thank now for you conference The today's

You may now disconnect.

Alimera Sciences (ALIM) 1 May 212021 Q1 Earnings call transcript