ALIM - Earnings call transcript Q1 2024

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Operator

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences First Quarter and 2024 Financial Results and Corporate Update Conference Call. [Operator Instructions] Participants on 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. A webcast replay of the call will be available approximately 1 hour after the end of the call through August 14, 2024. I would now like to turn the call over to Scott Gordon of CORE IR, the company's Investor Relations firm. sir. ahead, go Please

Scott Gordon

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

from leadership Financial me President Executive President Joining Alimera's U.S. and Officer; and Eiswirth, of Elliot Chief International President Operations. Maltz, Philip Chief Operations; Officer; Wood, team Todd Ashman, are Rick

During management and positive financial future position, making and guidance will forward-looking that achieving including statements results, this Alimera's or expectations flow. operational line call, time cash for address for be statements, future performance outlook

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

with ended obligation Except of law, reconciliation May language that earnings accompanies go Rick, that is release or time-sensitive pleasure conference in only publicly call call. to located Alimera The accurate these more as information filed please For Eiswirth. XX-Q, with explanatory Form risk the the press information the this factors on filed today. circumstances reports disclaims in about the EBITDA, turn well of call. recently call SEC for risks, most Rick XXXX. any non-GAAP information by SEC Alimera's any refer X-K is that filed the XX, cautionary is this table the as and events December to please to my Alimera's press Form release particularly Form as now required adjusted described this and update conference financial contains over that today, periodic statements Please therein. Today's XX-K the XX, to Alimera's reflect this which XXXX, accompanies to references revise or It occur as call, the after see ahead. a call measure. include the will year to

Richard Eiswirth

on expectations. morning a Thank to We internal quarter, first the you, experienced Scott, aligning with our and call. good good very everyone

direct to Europe. In acquisition some million, QX seeing net distributor markets we're increased the As key both forma on in global revenue well over QX, of see global markets as as U.S. YUTIQ growth pro integrating XX% to YUTIQ excellent growth of international of the XX% also XXXX in our our our by a demand, basis. continue $XX benefits in primarily and in consolidated we driven end-user portfolio, our

note revenue XXXX, QX may but that YUTIQ that deductibles seasonal resubmit each verifications, patient below is lowering is like reset anticipated the higher-priced as You of this and year for utilization their and decline this are benefit products ILUVIEN. physicians

As million EBITDA generating our this in achieving we quarterly communicated least EBITDA in in EBITDA and $X.X basis, at achieving positive year. million last on $XXX XX% 'XX. adjusted loss now $X.X of We QX an revenue margins million are versus XXXX quarter, a in reiterate we adjusted QX confidence

expect level call. We've to decile high end-user on due restructured revenue YUTIQ was targets plan a fluctuate million and XX% XXXX YUTIQ. EBITDA business. I increased acquisition as ILUVIEN in product. and growth each due to this and in effort U.S. a $XX.X on XX% the to also in addition our from softened up the including targets again integrating pro YUTIQ before, a combined quarter-to-quarter sales of primarily across prioritize seasonality the to users when of $X.X basis. In versus QX basis. As product to mentioned will the of believe our of the U.S. versus we QX QX XXXX, current and segment, the in demand net million for revenue due seasonality Adjusted consistent products QX fluctuate that our to is the against spending more to do We call year prior quarter-to-quarter quarter-to-quarter enhance forma X%

been year. Further, in to demand selling our aggregate both basis see December an the order monthly our team products and of to seen since accounts every as improvement for our growth the accounts of we've sequential last for starting our accelerate seeing has to we're X month messaging on and we're quarters slightly are the now, growth YUTIQ products of user end both of U.S. using and ILUVIEN We percentage In quarter both products, XX% as this in increased decisions cross-selling two tightening ILUVIEN XX%. YUTIQ. from the for to sales value products have

proposition, over retina utilized improve competition. permanent loss and is [indiscernible] refining and as DME, recur is the can retinal For ILUVIEN return of allowed catching we to swelling more If time. save specialists better this in the concept variability on acute the and a being to disease severity can lead and with are sooner as by the to value the higher [indiscernible] [indiscernible] to retinal retain consistently the to the level it vision. stay damage can treatments vision opportunity The there, off, were and healthy

posterior while PIVOTAL now a illustrates uveitis [indiscernible] for median segment that the It days YUTIQ, [indiscernible] data benefit. of For same the patient, recurrence is days it's the control that first study the XXX the time have less over than substantial the XXX for of chronic noninfectious the from of to YUTIQ long-term YUTIQ [indiscernible] patient, shows affecting benefit X,XXX for

Turning our international to business.

XX% We $X.X by year. end a in are increase momentum continued demand. the to user pleased revenue with In million. QX our international grew XX% XXXX, to net begin driven

France. have of is or treating by means patients broader U.K. among the XX% safety NICE, for up us growing the patient base in Society, only expansion this macular in United chronic Institute Kingdom. user NICE chronic has visual those surgery. [indiscernible] or edema cataract DME see DME to National [indiscernible] natural to According Spain Ireland, the pseudophakic diabetic guidance of Care population. patients the patients impairment irrespective and had now final for caused the edema is Macular Portugal, that diabetic recommended significant that now macular the potential fluocinolone issued for reimbursement represent at undergone to [indiscernible] sight. What and date ILUVIEN. that implant a Health or those been to is March, stated access U.K. our Excellence, utilization limited This the a have end to to of population In continue U.K., We or

to implant in potentially We availability after -- XXXX. NICE a the positively countries Italy. this this read reimbursement can out the This the Spain if in inherited States patients that ILUVIEN in our just study, U.K. benefit second across fluocinolone in YUTIQ. This will wider [indiscernible] expect half such We utilization other believe guidance specialists our other YUTIQ in of this decision with as variety will and January quarter nice noninfectious open-label in We also countries target affecting reimbursement adopted also and of study markets chronic EyePoint impact both the this half will Europe broader from second the our would impact broaden the potentially of in uveitis retina potential of which base for our as the of the like I Middle that will in we the clinical key acetonide highlight a well. Phase milestones synchronicity progress we patient enrollment to these sense the of and acquisition utility achieved next the now with of trials. year, I reached in continued few as NIUPS. of known in eye, a months United East. the and provide

and effects include cordon release of acute for patients registry abstracts clinical risk World study and corticosteroids XX% or injections to Jeff will protocol as fluocinolone edema Ophthalmology, and ARVO, observation, of AL. to anti radiation injections for with long-term retina repeated have demonstrating intravitreal for retinopathy. Research seeing visual melanoma week developing plans the macular plaque of initiated highlighting And development have networks also treatment. the that outcomes. Separately, Vision at retinal retinopathy. loss our acuity radiation study shown we XXX Congress, radiation with last time has the pharmacotherapies presented or implants of patients primary were continuous with randomized consistent I'll known CALM [indiscernible] compared therapy with treatment meetings. that in retinopathy outcomes we been detail. the the the the no The first are near radiation The Association brachytherapy radiation of our years YUTIQ trial, turn greater first review results patient the and approved at quarter FDA update, X X financial Elliot real-world been consistent titled, DRCR is for the radiation announce within versus And associated experience retinol and that to efficacy pivotal are intravitreal Additionally, retinopathy. This all study clinical The two devastating to for pleased there now the of safety prevention and vision to call forisumab in observation to randomized assess with currently, patients evaluating study associated of over digital acetonide trial

Elliot Maltz

anticipated, XXXX. Consistent million delivering QX we quarter the Rick, in $XX with and XX% XXXX net Street. to down patients' revenue resubmit practices hello, everyone. benefits pattern calendar completed fourth was expected XXXX business and up We in in X versus quarter plans revenue we year, the as verifications. the first of compared QX million Thanks, insurance from to $XX.X was results approximately quarter the change of seasonal see as the Consolidated

direct $XX.X to a forma X,XXX to primarily by markets user fluocinolone QX stocking to XX% in basis. operational QX XX% $X performance XXXX, increase was our to million XXXX $X.X $X.X France compared U.S. approximately our international XXXX, in solid demand demand end million The to the units end-user a driven up distributors primarily Looking million strong segment by at increase 'XX. in to QX demand in net International to XXXX YUTIQ. on increased in compared our XX% XXXX our in and the our our and increase of units QX compared for was XX% implant Spain. segments. distributors. Total was in due QX net U.S. markets compared growth direct approximately X% increased X,XXX pro in to revenue to from revenue XX% [indiscernible] in million our growth QX End-user of QX approximately a acquisition shipments and XXXX in in driven

anticipate EBITDA the in adjusted compensation $XX expansion were EBITDA of adjusted the the million of of XXXX administrative driven we marketing personnel again We QX positive million in to compared The approximately year. We remain this to expense YUTIQ noted adjusted QX sales in $X to million operating guidance, in call, was On our to 'XX. to $XX.X million of of $X.X target million by infrastructure Total margin is amortization last P&L. of $X.X the compared EBITDA approximately of Now two in relating will and generated quarter since remain a as products $X.X rest increase as million looking $X.X expenses, expense. Net adjusted to generated $XXX,XXX the stock-based $X.X U.S. million and $X.X first as this increase in of acquisition quarter-to-quarter but attributable selling May expenses QX seasonality. XX% of commercial approximately additional XXXX. in of but approximately confident we 'XX. our due well $X.X primarily million at approximately adjusted loss general quarter million EBITDA XXXX expenses fluctuate to we that full the QX attributable compared XXXX, to consistent, revenues as in our costs for and of margins additional XXXX relatively was in expenses million well planned. fluctuate as an in loss EBITDA approximately QX our support

XXXX. million of at March $XX.X of compared cash and the cash equivalents million had XX, we approximately As to of XXXX, end $XX.X

quarter, consideration This EyePoint of more million which Partners obligations, provides YUTIQ in operating the increased such owing our us our the phrased from and last flexibility by resulting of agreement year, paid acquisition with upcoming be in $X.X was Capital of lender March. term million. as impact we $X some contractual to This $X.X million loan with the XXXX, SLR of

$X.X XXXX. Additionally, fees remaining exit during million loan with SLR, and $X.X our agreements under million QX expect trigger the revenue-based term milestone to rest triggered we XXXX, fee and of the we over of

give it closing his to to turn I'll back Rick comments. Now over

Richard Eiswirth

Thank Elliot. you,

guidance. our internal we pleased XXXX, said, with and to previous was we our expectations are which start As with consistent

against and However, to ILUVIEN success DME utilization in leading YUTIQ and XXXX our of markets remains a beyond. prioritize uveitis opportunity. franchise believe indicator the a cross-selling which and United there believe our level for can that enhance growing both restructured fluocinolone plans our with and the invest, international significant in of accomplish high-decile acetonide and in utilization in will what product We ILUVIEN call effort States. We grow of promote the is our targets current opportunity users in we each the

earlier the since [indiscernible] of utilizing signs that we sequential that will monthly a with demand seeing studies percentage early an successful NEW ILUVIEN uptick As conducted I accounts around products. We have commented support study ILUVIEN the and outcome earlier, good we the indicator world of population. year the of in margins. Thank DAY specialist and success prepared YUTIQ believe increased DME. are believe growth I'll deliver And in the the and are a use you in We remain numerous we questions. with believe both the very in report greater the of XX% we the much. treatment to over confident synchronicity concludes paradigm That utility general and revenue ability for this highlight $XXX EBITDA for million in remarks, our will retina than now study than turn more call operator the our to

Operator

Chase from Craig-Hallum. comes Knickerbocker question first Our Instructions] [Operator

Chase Knickerbocker

first for of just me, a Maybe qualitative one. more

of to force indications. synergies sales how finding might have of a that harvest for looking much be sales just getting kind drive as Just that for or are you far not there out kind -- in upside those as how positions warm is more a of Are DME, product might -- combined we're as still -- go example, awareness. of aware you're your uveitis to going lot is and both indication the using the your water the still force synergies of sense as engaged of maybe

Richard Eiswirth

sure. Yes,

clinic extent lot we now I bit they're issue, one trying a know get few to short and are in more, the comment conversation able ask is awareness same some there assets Chase a to be the out that on a to a product. sure think clinic been it now. [indiscernible] an has I Todd are think using about it's on making window It things, where combination road products team both our about the talk figure for to of with that but in team a how is streamline quite would because that of doctors have competing to the they challenge this the little time I'll both

is been getting And both messaging. how you're to talking the trying trying conversation. to so to less little But about in and you do you've and talk more doctor that Todd, to bit clinic want the a time squeeze those in the same of refine

Todd Wood

Yes. different Yes, on what to that because for Thanks the specialists. currently There gets engaging to providers we are in sometimes on education to is campaign inflammation for uveitic. many different that patients uveitis certainly. And an what And it add DME. Rick sometimes on of uveitis are classic just are because referred question. mentioned, there's chronic and are states a disease

we're on And tied of another not it's lot uveitis though fact that they a uveitis, so providers disease. even to it's seeing educating the are classic probably

crossover. what that currently that's right to implementing we're create So now

Chase Knickerbocker

strategy rebating looks taking Got a the any done here of drive And early it those conversations kind then rebating any line. of Taking staying Have been the any in demand it. either data, these line sort of the tech. of of to from U.S. thought some the and on in maybe on look initial drive forward kind same initiating at it extra combination potentially there's you given ASP product indications never like to help

Richard Eiswirth

more consistently. are are or little practices back for consistently. value both products in YUTIQ We physician Yes, back X, a value those a program YUTIQ. Chase, been program frankly, call that. there's practices but value then the nonclinical it April timely a we a that a it's as it -- where implemented at ILUVIEN there's And as using to have more to have more providing value of And we actually provided aluminum looking that for nonclinical the we are program, We using separate refer question. the bit U.S.,

rolled It's impact -- as implemented QX we but impact small year. on April and do the in that have expect been we that So X. slowly we'll greater out, move throughout we some an impact have

Chase Knickerbocker

to sort willing kind your Are or here? it. nonrecurring just spend, you as quarter? items of conversations would there I model to [indiscernible] from you then Or Sorry, if initial of customers seeing sort And on add in the any any marketing noncash that that and Sales that was you're value flat of nonclinical missed expect to be on impact the potential well? side. new from

Richard Eiswirth

Well, from to -- comment Yes. the the some Todd Amplify program early we've we're it's ask I'll to as value, Elliot feedback of gotten on on the what the nonclinical maybe referring the then on financials. can address and the comment

Todd Wood

anticipating just got marketplace well. positive the feedback. something been this initial they've greatly The It's has we've amount feedback -- some very like for has of launched a as Obviously, been time. Yes. we've tremendous And it, accepted.

is see look purchasing to that patterns Now throughout quarter. this of a matter it's type what their impact the we at end just of as

Elliot Maltz

'XX, of number, Yes. which expense did very costs bit higher and of X% about than the normalize XX% quarter cost that terms in in go-forward material incurred talking in but And P&L onetime not quarter on with as we're the this of maybe marketing were the to a have in regard marketing. to year, and move what was line, just maybe we sales the I anticipate onetime that through first sales quarter our a total rest should we the a during We in this think some basis. range

Operator

Company. from Chen H.C. with Next question Yi & Wainwright comes

Yi Chen

your With the trial, respect study? AL to does protocol [indiscernible] support Alimera financially

Richard Eiswirth

am I question? you that. didn't I sorry, understand Yi, quite the can repeat

Yi Chen

with AL, injections. the study [indiscernible] DRCR Does protocol financially study? retinal this to The Alimera network [indiscernible] fund

Richard Eiswirth

the the of straight period the years are we or of million over Well, of X over course making about pretty X Yes. year. lined contributions $X.XX it's and

So million year. $X.XX a it's about

Yi Chen

could there that Okay, radiation us potentially patients on some benefit give could you color many out [indiscernible] okay. retinopathy And how

Richard Eiswirth

probably out at there's an same a XX,XXX population. It's would time, nothing it I it year. time. this approved to there patients be the a less orphan than small indication, treat considered mean, at disease pretty But

Yi Chen

Okay.

access the the nice And Okay. I the to [indiscernible] from how with on large more line DME regarding recommendation impact revenue for is the chronic U.K. do expect -- mean, how you see? [indiscernible] U.K. patients having much top

Richard Eiswirth

XX% the give [indiscernible] hard around DME specific is about that. of guidance It's probably The to population population.

unclear. However, it for these be utilized U.K. How it greater But chronic this market we little get you the able will where it. or We'll some with quarter overtime, identified [indiscernible] can patients after that would they've of a specifically think be a we more of it's do a identified a -- the bit of patients in bit we where in probably to probably bit hospitals, on it utilized that little the the already being certainly, more adopted But the in tell got they're being utilization and be double have U.K. patients be will little in than available X experience patients know still it's more quickly ILUVIEN. are in

give it's another guidance but much won't up, starting quarter pick be we So to out. or to until able X probably get

Yi Chen

X,XXX the it. is units the and Is U.S. territories. Got ex the it. that Got And [ for correct? user U.S. that demand, ] including quarter,

Richard Eiswirth

correct. Yes, that That's is correct.

Operator

The from Naz Group. Maxim with next question comes Rahman

Nazibur Rahman

the progress. on Congrats

how I also margins? in U.K. the on could international couple. means from U.K. bit. what later translate for the to down reimbursement implication territories? improvement, line? better management the any, you it the the expand if Like, to margin on the reverse potential And U.K. want the reimbursement how that your a in is Just comment question other or Could a the differs how little

Richard Eiswirth

a across an where doesn't Philip, [indiscernible] So you -- to impact on give [indiscernible] at margin because reimbursed little commentary maybe bit same have the the still really Naz, could Europe. going the on But reimbursement we it's change of reimbursement price. us restrictions the be have change doesn't

Philip Ashman

Yes.

that U.K. adopted of [indiscernible] one this the So limitation. countries is the

way well. work, include as reimbursement Europe, another. And speak Italy, the The unfortunately, authorities other and all Spain these of to X countries things in

a So is which But implemented. at translates and even there's how -- guidance April. in in it in have that interesting the Europe. U.K. clearly, We now don't see dampening to across of countries will end place -- on limitation, the it launched impact the be it

our with can there at help it with Italy the that too. limitation countries, in because and plans at been So there, for it's in we're in to we those to working to look carefully no all But watching echo And change Spain we're how an important them partners see and how this. hopefully, progresses already Rick just helps. what has point, said, price challenge

the in Kingdom, that United we of So volume through the in what requisite the impact with volume is the sense expect more of overall coming revenue.

Nazibur Rahman

it. was That helpful. Got

pipeline Our next on question or is the indication expansion.

could other you're call, potentially indications? about more any You a RVO also, seen either potential And use mentioned thinking? the you off-label [indiscernible] you have of or little on expand what

Richard Eiswirth

Yes.

I to think looking been we've a So for we discussed. expand at perspective, indications holding opportunities some boards as Alimera from pipeline potential advisory the and

now population we to that would what us back patient but know have exactly sort would vein leading with those that something We board of works, basis some end look of advisory there the on probably that that uveitis [indiscernible] that treated chronic are and in be need come lot found something We patients well available where a to RVO. that that low-dose to with a do out as NEW bleeds potentially physicians use a hope the physicians and like would a hear think have DAY look of refine DME utilized trial try synchronicity potentially we that and like spending DRCR trying between to out work a redirect that's there's with I candidate from the flush have for and beyond what RVO of long-term are it occlusion. their arise have the we the study, cases and the and patients year it structure where signs or as compassionate could down. and of to from steroid

Nazibur Rahman

question data some some when or color then provide we on conversion data Could at? study the Got that last And comp UT. from see my might on for what is be it. might you study presented

Richard Eiswirth

Yes.

in it's slowly and that a publications by study. was of that the study, participants sort registry So producing

the and day reason the you see self that, ] you every they were just World there capacity the as at were frequency therapy. safety this presentations presentations share we why are are see remind at And World well. couple they're what very in consistent same the setting with over registry the fluocinolone part, a because of for -- and patient those weeks. and As Once injected is uveitis. Retinal ILUVIEN you injected not published, have low-dose and the studies see that deliver ARVO it the is to X in Congress for two seeing yet. across those three just that And most they're anti-VEGFs compliant. efficacy it's are the at papers been reliant saw -- years be meetings. shared doctor's DME the [ therapies past because to real-world they're general, you And but for back were in acetonide you're eye, are, in we'll there as They same papers YUTIQ in results we mentioned, able there you're consistent with getting both on the they not very, what saw the to showing the don't pivotal the consistent you studies. -- is clinical a studies like But at other a of what that the very office office for publicly, the acute I'd and

Operator

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

James Molloy

in looks that sort the sort Is $XX to know thinking quarter fourth the the and better in in the marketing last of first with a you to EBITDA kind get I do what a and sales had margins that you on margins. see first margins going similar Or the expect besides do [indiscernible] but sales? million there able of in through see way the that question quarter? the the year? the to quarter from first better year quarter. to seasonality [indiscernible] margins you of -- How improve the happens -- it 'XX quarter, guys margins the Or it's third gross from posted of the guys decouple to you I quarter I here. in would be going

Elliot Maltz

Yes.

of I the there new and were some but of majority fairly items, our one-off That's that services opportunity both U.S. expenses integration keep a align relating hub into some the product cross-sell nonrecurring meetings single train structure, are So reps products. force to two tied business There mean internal some on having hubs fixed selling P&L hub our some there that are in having the of supporting sales were the in costs from transitioning on first each to quarter the consistent. to

the the the costs an structure on And now some really have cost EyePoint indication a reflect individual that done. they've down P&L versa quarter. believe with our from are majority of should opportunity. for came the those fixed last DME taken employees fewer we needed weigh one-off P&L Alimera for on have basis, the go-forward focusing of those items legacy and their can as that We that year attention, that vice and training more uveitis and on selling We

that we guidance. in basis, the the on move of costs our year as to a get to full rest through So that indicated And XX% expect remain margin we fairly we our EBITDA stable. year, up

Richard Eiswirth

coverage they X, systems and April et complete understood were the we means parallel of that costs was Jim, more cetera. -- and piece two last integration we for April until incurring bastion where hotlines -- we operational was the X. completed One physicians' the as in of sure was provided as last point integration which co-pays, X, where April in benefit run offices there the benefits of to running on make We EyePoint insurance and were

you that's another issue So see.

James Molloy

and quarter? expense And that sales goes into the in marketing

Richard Eiswirth

Yes.

James Molloy

the versus [ Then with YUTIQ the out in -- U.S. can quarter? ILUVIEN you guys ] break the

Richard Eiswirth

We're the consolidated of going forward that ago. couple Europe talked doing on not going it -- it's quarters forward. fluocinolone that because going We're in going just basis, talk acetonide like we a franchise about is about to a

James Molloy

How reps and field, received. think and that's I anecdotal question. Then been bit the guys new little talk you Great. you many the messaging the a field in currently how maybe any Okay. last in have on about stories

Richard Eiswirth

on comment but feedback you in do we've now, Sure. U.S., to the the got Right on Todd, territories that? messaging. I'll to Todd want if XX ask

Todd Wood

this received derived sure. messaging been look been has with quite the of the messaging at where Yes, that a is team this front been little Philip from bit and well. And experiencing have out before internationally. you U.S. we're his The growth has some in

vision. the call. we've so earlier. when also recognize mentioned then of that our with their They with the the prevent new you into thickness. proponents look early fluctuating retina our account to on advocacy treatment And better Rick and they it paradigm a thickness vision. product, top they're around bit key impaired fluctuating at is of to [indiscernible] And intervention aware use, take really bolstered lead impaired that, little of that And can efforts

how that's the of advocates the ILUVIEN product using So today. are

that to we're base that get broader there from initial with since So a more the board is on advocacy momentum trying groups. and expand people to

Operator

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

Richard Eiswirth

report Great. Thank sharing for forward when your and quarter Thank in We good you, you I'd progress today's results and look in continued participating do everyone we on day. thank all, our August. to a Alimera. ongoing to second like call our and interest have

Operator

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

disconnect. may You now

Alimera Sciences (ALIM) 14 May 242024 Q1 Earnings call transcript