ALIM - Earnings call transcript Q4 2021

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Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera Sciences Fourth Quarter and Full-year 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. the end be May of of hour approximately XXth, 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

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

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

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

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

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

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

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

Richard Eiswirth

to half as to in call. pleased return strong We're good from improve. the EBITDA in [Indiscernible] positioned finish to we XXXX, year XXXX, everyone revenue of XX% million consistent the recovery to on report for physicians Ocumension XXXX, I'm delivered second $X.X XXXX. adjusted reported in fee second the the and pandemic. year, access Western quarter LUVIEN growth revenue adjusted Thank up our you to that morning in full in in of million sign a We to in more our $XX the driven net formulation to compared license of of received the XXXX, growth Scott, of very and I continued our the that the on EBITDA now business $X.X we to which Pacific. U.S. year continues We the compares by a to million of

took we was driving connecting seen We mid-year our increase early we've as up second U.S. initiative XXXX. of the on in end-user XXXX. in demand to the half Importantly, investments the investments with growth these and returns in believe physicians in

since XX% quarter In We best up demand despite growth finishing in quarter third for quarter XXXX, fourth the to the being for a of the at XXXX, variant. With on ILUVIEN compared surge Omicron quarter, of acceleration up of the unit first end down end-user with was our almost over the year the bent quarter of indicating And XXX the U.S. basis, the despite year-over-year, we demand units volume generated the our XX% in of sequential rate. XXXX being our XX% up over the pandemic. of the fourth curve onset the U.S. XXXX. end-user X%

and sequentially XX% the from in GAAP of a growth We sales reporting had of compared quarter of XXXX, fourth to a U.S. percent million, XX% strong the XXXX. fourth from the quarter U.S. perspective, also third quarter $X.X growth

the clinic, efforts. and Our and interactions, strong performance inside face-to-face advocacy was driven both by of increased our outside

for opportunity is And We has where a U.S. our believe both we to we desire there patients the to This to marketing the reach prescribing believe potential fewer in need is designed campaign and excited have or areas ILUVIEN with better, practices. campaign to DTP, for pandemic patients launched highlighted injections. our are in We appeal see direct-to-patient, have significant ILUVIEN to longer, mid-January. patients who high physicians.

that DTP campaign XXXX. may pilot and ran a You selected we successful in recall markets

increased XXXX Our have as are U.S. Early in patients we're streaming our campaign, us the based our display and non-branded behavioral ten large social already and and campaign ads with maintain targets see longer, business of The goals of a X.X We in benefits. since sales demographic reminding physicians US qualifications. consists more the in site. educational began. by And believe weekly launch the impression tactics. times DPP that ILUVIEN momentum campaign media, traffic and digital to of regional as trending video fewer markets other on the spans well and diabetes, better, ability has prevalence with DTP Namely than the above Iluvien.com this help to a on campaign website our that our will injections.

was business, it throughout to our caused the that in access variants. COVID-XX challenged due international to year, note Turning the severe we Europe restrictions the by

in XXXX Pacific. year-over-year these to million, including $XX.X ILUVIEN our March. up February International the $XX were received from Ocumension Fortunately, for and in fee markets the sales upfront we XX% restrictions removed during are that million we seeing Western license for full-year

$XX.X XX% full-year fee, to the international $XX million Excluding XXXX. in our license XXXX ILUVIEN from XXXX declined in sales million Ocumension

limited primarily a in shared, the first XXXX, inventory was previously of to XXXX, restrictions. due variants see result the to half late we of As distributor our demand international building in and only this partners

in which our quarter. at and and and see the and in Despite to global the However, posterior ILUVIEN entire positive we of in international first restrictions. on of noninfectious pleased only course growth despite continuing mandates markets execute since DME XXXX. quarter the treatment COVID-XX treatment countries, demand and to the the continue to European is end indirect for of of available third segment, we XXXX, in the both for on In across the countries, impact end the challenges end-user XXXX. At Czech posterior And of were XXXX, DME both and in at available from the over the before importantly, We an direct uveitis. the our ILUVIEN expansion revenue of including the completed recently non-infectious some nine was the the markets quarter over of XX the highest late was uveitis segment Benelux of Republic we X% the pandemic, sequential the standpoint. see did our fourth trends Nordic the countries of other stay international XXXX added quarter, compared fourth and availability home in approved

due the we pandemic. We're restrictions support grow to restrictions from the However, of neither excited and to the we for nor the for our our these DME commercial anticipating XXXX opportunity the access in partners provided uveitis are Further, growth as significant posterior indication. elapse improves. markets in opportunity business

in approval You announced this may recall indication month Spain. that pricing for we earlier this

be in reimbursement into the Pharma, in options in for Our the launching this where additional Europe, markets turn segment. our expect now who XXXX. We're to to by financial with obtaining UK. as XXXX, our the the for of the in a over evidenced been to growth will full-year. lifted. X. care commercial limited. on ILUVIEN quarter international lead X. partner, inventory reimbursement for this markets, market levels our this, posterior in are Germany X. with and appears partners, X. improved new is call lockdowns Prior uveitis distributor that, being to these Brill to in in to and only normalized and working Access and our Phil, increased improving And uveitis activities and I'll for treatment review launch marketed markets, access, had will few believe now results in the We posterior

Philip Jones

Thanks, everyone. Rick and hello

approximately to million quarter $XX in of revenue million was consolidated fourth up XXXX. of During X% the $XX.X compared the our fourth quarter net XXXX, to

distributors, driven net from Our consolidated in up U.S. of $X.X the U.S. of XX% third of to third by quarter an units segment. U.S. the of the was quarter the $X.X XX% to quarter fourth to sequentially XX% U.S. quarter higher revenue in XXXX. period. the business fourth net compared purchased million end-user net approximately XXXX. was XXXX our XXX demand, XX% compared fourth our by physicians quarter XXX revenue represents which XXXX from increase in increased up compared million sequentially for the units of units XXXX, pharmacies XXXX, sales our and revenue the was reported in of to

demand end-user XX% grew third indication of treatments. U.S. XXXX, an However, sequentially quarter in versus of the recovery

compared medical reported year. to in due $X.X approximately same with our the treatment of were net compared customers promotional correlate fourth This fourth the reported Net spend markets. expenses for operating million shared, do in quarter As reported the face-to-face QX always in to purchases going million XXXX, COVID-XX EBITDA of of our decrease The XXXX. compares the uveitis to international better XXXX, our and higher medical in -- kept XXXX. fourth from timing We specialty sold fourth decision and of $X.X increase growth to hospitals as DME XXXX, in fourth operating by to the loss due the segment the the impact and $X.X ILUVIEN of increase COVID-XX and to earlier. million purchased international million limited The In units of for an revenue to Total the their approximately to last the end-users. expenses million we our X% end-user for in mentioned with promotional both due were was $XX.X patients not distributor have million to distributors our our our direct increases adjusted come in to This ability which due becomes adjusted XX.X% managed. to GAAP U.S. more $XX.X XX% Alimera's posterior quarter were an variant, in demand quarter from previously our accelerate $X.X of EBITDA of decreased distributors. approximate revenues and quarter expenses period than quarter in to U.S. of positive to consolidated revenue investment as XXXX. of was

share a the XXXX $X.XX net quarter was million December net months X.X loss of million XXXX XXXX, approximately per approximately for Basic shares compares approximately per and weighted on of a approximately share $X This loss For basic three on the to to and quarter outstanding. net diluted diluted million, we the average loss $X.X ended of XX, fourth average fourth ended of months XXXX. X.X three reported million $X.XX for shares loss December compared for of the outstanding. weighted net XXst,

Turning XXXX $XX results in the million, approximately from revenues were an XXXX. year, we full that the $XX.X consolidated for increase XX% reported our million of for net to

Western the we $XX.X compared the to in to 's XXXX medical primarily and expenses year-over-year the recovery with million and agreement formulation to our XXXX. post-pandemic. to Our license were increase Pacific. revenue our half our in million, technology in operating to from total operating growth for an investment in XXXX The XX.X% Total decision due ILUVIEN reported Ocumension included commercial $XX.X increase of and XXXX rights sales $XX in increase received in and million that second of the marketing drive activities was in China expenses

For we XXXX. million EBITDA reported $X.X in to the of adjusted full-year compared XXXX, $X.X million

December of $X.XX December And diluted XXXX weighted loss for equivalents cash diluted we Basic per $XX.X share shares to with and compared net shares XXst, December X.X to ended XXst, the we On approximately $X.X weighted a in it approximately for outstanding. and turn year of had cash million $X.X year loss outstanding. cash and million back and equivalents XXXX, XXXX, to average the For This $X.X approximately XX, to basic we million of $XX.X that $X.XX cash of average million on per XX ended net million on compares XXXX. million Rick. net share net I'll reported that, reported December compared on for loss over loss was XXXX XXXX.

Richard Eiswirth

these from of you, of publication little in Thank to three-year efficacy the sites. PALADIN The label, DME. to a study, in up open before study confirm we risk once a course the of lowering we the results questions, observational surgeries. of Phil, results PALADIN ILUVIEN medical of treatment the our journal and U.S. using a safety was and new the believe Yesterday, the share I'm benefit corticosteroid We the again, indicated favorable announced excited Phase of in Ophthalmology. data bit that as for ILUVIEN. on was XX designed clinical prior developed IOP four, mitigate in U.S. to was of perspective study three-year conducted across the confirm

to the with burden looked following XX to of three X.X ocular at measure could a for. the eyes analysis Study the for in are And the hypertension required of that period significant companies provides compares only significantly data experienced time demonstrated earlier received acuity. the to statistically more better the to for treatments administration the for the with we demonstrated improvement. decrease points, the mean durability number these earlier visual heavily But after just in XX-month ILUVIEN, to treatment year. who U.S. ILUVIEN edema ILUVIEN the eyes eyes acuity administration more importantly, of favorably received or visual many the already desirable gained before treatments a ILUVIEN outcomes. patients. study, visual pivotal received that further, searching Functionally, ILUVIEN baseline. patients one of implant what and This in post-talk acuity And treatment half letters use and months is treated treatments. the study DME Importantly, treatment three ILUVIEN This all benefit parameters. required X.X% however, the And significant a seven visual a from outcomes. eyes PALADIN of than significant in measured per ILUVIEN frequency statistically surgery, the DAY expect study completed years was years achieved X.XX% a again of of In central the when of two but treatment fame X.X ILUVIEN of prior IOP these lowering prior retinal study Eyes label. letter only sub-filled improvement in of The that acuity. a frequency place. to accordance at outcomes year. seen three-year that reached patients follow see or treatment a intervention. significant thickness, of decrease during treatments medium were increase as the to The of of represents DME per those a statistically steroid period therapies. induced due Demonstrating three-year acuity algorithm key letters other before in visual in receiving six X.X% reduction several other compared in this a had Study. declined lead treatment in also study. suggests patients fewer the patients receiving ILUVIEN, the XX.X% This to ILUVIEN mean up exactly in experienced same in more letter in while NEW medium an a post-treatment, X.X in Reduced treatment ILUVIEN was Anatomically, that This loss X.X

and As designed leading demonstrate that, DAY Thank head-to-head over anti-VEGF I We will Study advantages repeated strong significantly our suffering for reduced the of to the as the patient is clinical of turn anti-inflammatory from improve call over in anti-VEGF you. ILUVIEN ILUVIEN baseline compared injections ongoing reminder, landmark is that to injections And to need our NEW long-term there therapies. durability Operator treatment patients the trial, the frequent now properties naive and near-naive a the believe therapy evidence questions. and for recurring outcomes and 's with DME.

Operator

will now question-and-answer At we momentarily, to We Instructions] roster. our [Operator the will this session. begin time, assemble pause

will Please Craig ahead. - Nowak The Group. go first of come Hallum question from Alex Capital

Alexander Nowak

Study. the everyone. morning, let's Great, piece good last DAY there the about start NEW on Rick,

you're and the that create enrollment community, how the hearing bus PALADIN maybe renewed already is read the the curious DAY, this studies then begun from Just a around And even in is to essentially with kind new there there ILUVIEN, before progressing retinal combining forming on interest might out? of day there. study NEW what the

Richard Eiswirth

and for thanks Alex, your questions Yeah, good morning. great.

a start around we several pick PALADIN to bit We're doing a We progressing; the past participated can actually they Study few got fueled to year started up and to also between holiday I've I I've the think seen and fall New well. responses probably down this little in things So see enrolled did noise in it back to that's that week study enrolled quite in XX% comment over your we of It on enthusiastic once in the got these the get enrollment pretty little and the this over saw little to everything pushing actually results holidays and we're are as XX% the are, again seen Day To what of trying speak uptick but we we and enrollment is and the push of still a to study. bit got definitely little up [Indiscernible]. where results have those the bit. these interest it a study have out an bit past excitement open season, slow as investigators doctors myself up. about a it to reached as seeing and and them asked study, keep enrollment

Alexander Nowak

maybe on that was takes excuse rate, million is growth good that XXXX. any the wanted kind great. saw that's off puts as in you we start me, comment know the to. of run there get we of Now, there some I here the back sales rate that for kind expect year. we run here QX, rate from And the run the XX Is to throughout head base that of is to and a or then

Richard Eiswirth

Yes.

I from building place in there. a think real we're good it's that

of France. off coming some the Germany. of example believe a day in of pretty U.K. we're coming we're you end off restrictions well. generally in Ireland in as with As and the experience lapsed I pretty XXth and early some Europe, is bit the We as I quarter, in U.S., do first seasonality typically the we said, doing the know, for are in March little significant restrictions the speak a dealing still restrictions January,

still dealing restrictions, So in way U.S. of we a that with the pretty and can and to good the expect continue feel about the in growth Europe. ended the we're year growth those but to we few we return

So we we I this restrictions, did we'll year in grow I that we back you don't think in point that the of this without through quarter spot don't we're a some towards and know to but can year end get of know, I where to deliver, year. the get the those deliver at expect numbers until certainly fourth good there XXXX

Alexander Nowak

beyond then what new some growth Okay. marketing the here else U.S. That's kind programs, new XXXX? growth sales about marketing, plan, of just this maybe tactics be direct-to-patient program, details sales to And can great. on thinking for just more as done you're change

Richard Eiswirth

Well, XXXX we of thought-leader -- ways did throughout in over add science some MSLs to some engagement liaisons clinic. and medical increase the course the liaisons different the

said, medical think doctors paradigm, use sale and about of lot trying the As more is are to earlier characteristics anti-VEGF. the something way get I've a we there's need that that changing the think we a always than the make treat high that because well these you to they ILUVIEN patients, in of it as disease

education things. holding of and boards the around of those medical types increasing a as advisory drug So lot component the well,

behind think engage programs probably the or it's medicine done educational to the situations board I to most science significant and in find ways the these drug. we've discuss is doctors the advisory thing

Alexander Nowak

a does a sheet forward. of up usage that of rate a net the or quarter? XXXX? rate starting question, year in so it's Where what cash here balance year? burn was cash Alright, then on good parter, going we at to little run is on about And bit - then rest the growth last was thinking the a cost the end the the QX. side. two Is cash don't for the the marketing The managing for in that be just stand spend And going the run and sales then a but of have and yet,

Richard Eiswirth

mode somewhere due the that mentioned for And it Yeah, cash throughout to quarter. the those travel and stymied places expense of back Yeah, model of use would there and anything did slightly, the this run fourth good at we Europe such north return the again, the question. Alex, been Again, the we me everything, of out the degree suggest And frame. if XXXX time at the looking be and into the more just for travel fourth for pretty rate the probably quarter, that normal I've about items and by some if call. fourth other to of we as there, missed what just know will get to you answer of run come that rate investment $X.X and quarter is the is I'll understand have we that as that to year a pandemic. million within look we let a was burn that some back lot burned the to well,

Alexander Nowak

the No, but update. good. you. I Thank think that's appreciate I

Operator

The of will from question Global next be Partners. Alliance Molloy James

James Molloy

I guys morning currently taking I the was, many guys year, have currently But the know --how you your reps you'd this reps. in about the good are with year, talk with part Hi, can how past for any. wondering sometimes through questions. of my little was the first if a these thanks happen turnover guys up in if turnovers bit you standing experienced reps businesses.

Richard Eiswirth

has our so Jim retention pretty good. been far,

I by us for situation. that's And the better we trying is rep I that's driven of normal the to territory. the and to right turned sometimes a by think XX% opportunity, think pretty the last frankly, over find year driven having another territories, probably XX% which sometimes rep,

of significant this it's part to year So been those in trends. the first far. pretty No so changes good

James Molloy

How many there reps currently? are

Richard Eiswirth

one XX I right believe now that territories point. got got vacancy We've this out at there and we've

James Molloy

to with and the MSLS. there Okay. that advisory Looking doing presume or boards? I ILUVIEN sales point weighted Thank the how it's having sales hit quarter sales advisory upon boards of these we -- the much of to fourth you. sort very in is much And, these these at back in [Indiscernible] marketing How obviously couple the for decouple of of you last, a number and COVID, [Indiscernible], through around to then on items upward as of high COVID and before marketing goes [Indiscernible]? right 'XX, had you've way excellent heavy very and get there that And XX% remains do sale to to an go well, little to you bit a had spend XX% with touch Ex XXXX, a see person person the to we're sort last to to years trajectory. you do sales. sales the this about need of the Is of about ILUVIEN sales --

Richard Eiswirth

So of the that questions you they asked. are. a couple of frankly, there, The type -- the of the where where amount spend the Jim, depends advisory boards on and are boards advisory

if medical are educational boards, to frankly, that more of So advisory medical most in spend in this there is sit they're the and effort medical, at time. point where scientific, they lot going goes affairs affairs our of a

results quantify get growth We we things DTP I messaging hope that's that with to that lot of the to to I'd frankly, back higher and our refer and like the to question, resonates and can NEW piece, it's that 'XX, into. was the tried - in point think to and pandemic some as range. get we the where you DAY restrictions of each 'XX, quarters a see don't to as if doctors of comparative a tell of you well quite growth ultimately and also far where our advisory drive probably our get the look evaluate rates the in probably can with hard at And as is sort 'XX, back 'XX break where commercial think sit so course over of we out growth growth rates you were, your out boards few completely. our if back will we Organically, that's the granularity the that want 'XX right? how number we we Study do once that I doctor, decoupling XX% another to commercial of to and touch that reported

James Molloy

question, Final at fact shooting sales impact are Europe, that in all? each at other does the EU they

Richard Eiswirth

a it's little bit to a it's early probably little say -- too too probably I'd tell. bit

around fuel point. the in I place it's would about I or or in probably impacts the the to to early doctors little cost things start think like and But guess like that. that move -- is and at get countries to as tell one a ability visit of worry to person patients offices that things this bit people's too I the

James Molloy

Thank you questions. the for taking

Richard Eiswirth

You're welcome.

Operator

Chen of HC ahead. question Wainwright. Please go The next Yi from will be

Yi Chen

questions. taking Could comment you for plan have and market to Thank -- in feedback market on whether from as whether for your have patient you any direct-to-patient direct-to-patient you Europe well? my you campaign campaign

Richard Eiswirth

sorry, end of question. the didn't I'm I hear that

Yi Chen

you Whether --

Richard Eiswirth

Europe? In

Yi Chen

Yes.

Richard Eiswirth

Yes.

yeah, to patients. first well, In thanks morning the first -- of the the I second can question directly good can question we're -- answer able the half the So not first Europe, and the not market all, -- allowed for I question. answer that we're of first. under to, to regulations,

this time. do but in early. don't is on we from very those no so Europe In you have patient patients. direct We it's have started traffic tell is I campaign this coming that the site what in U.S., can mid-January, at there Direct-to-Patient yet, we Iluvien.com increased our So feedback

increase XXX% January on traffic we around started we since in that. a And I started or than more we think so. So Iluvien.com saw XXth

treating is early. appointment site, point. be to important an funnel can though that to patient find-a-doctor drive because ultimately some already that's So there that It patients actually that minimal and at is a a to to where it's try go a there ILUVIEN where find that very through with have usage doctor traffic we the would

frankly videos this than are you and at impressions like also advertisements on non-branded by we our early tell in out. seen can on internal The to goals we well. expected our site. looked things that branded our and of we I thing roll are for believe Both other and is definitely to The as ahead and the our more being people advertisements

Yi Chen

countries distributor? the as for European ILUVIEN will had have you've What Okay. launch

Richard Eiswirth

both as released reimbursement Spain we've of we to of is launch right on reimbursement are due hope now. in and partners it by get the has reimbursement a of in the offices -- our get expect We and year. right to half ongoing middle of [Indiscernible] continued And stops to the the the countries, in starts year there Portugal, lot close those now. to delayed various open been the pandemic. everything and and working Italian French by first they've expect we

the We expect in that and things we a behind at as partner our that, this French there are is more have put in opening point commercializing effort Territories Benelux and well. bit the product reimbursement the now little to that up Netherlands

pushed uveitis pretty end So, the we see year. before expect the to in few hard of countries quite a

Yi Chen

could And comment in level could whether the you and you inventory at right. forward? going initial U.S., -- the see remain stable on the the level All the distributors level

Richard Eiswirth

that U.S. the inventory was throughout in stable The distributes level pretty the year.

less the amount standpoint. by I we from ordered that X% think through distributors what end-user than or demand difference there of the product sold was X% versus was a in

was So that pretty steady.

was You pretty looks whole. returns. the the pick March phenomenon a course drops they as see of it bit to of of off they We'll the to year have man down over of months seasonality, then always end-user XXXX some as first volume like where up steady over and in April again of and slow buying get this the little the couple little the because of bit a start the quarter the what but that a because

Yi Chen

Okay. Thank you.

Richard Eiswirth

Thank Yi. you, Yes.

Operator

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

Richard Eiswirth

appreciate we on us in call. you for and your And joining continued today interest Alimera. Thank participating the all

progress very results We we report our to ongoing first on are later our in much May. when forward wonderful you quarter day. Thank and a have looking sharing

Operator

all you, the is presentation. for you conference now concluded, today's Thank thank attending

your Have disconnect now may lines. a great day. You

Alimera Sciences (ALIM) 24 Feb 222021 Q4 Earnings call transcript