- Earnings call transcript Q3 2022

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Operator

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera Sciences Third Quarter 2022 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 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. the end be February 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. Please go

Scott Gordon

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

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

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

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

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

Rick Eiswirth

XX% on international are XX% Both both up to ILUVIEN ago. performances quarter We're performance U.S. over Thank Year-to-date, and with we XX% the demand, and pleased end-user have were delivered a everyone strong the segments. period global same the our up in third demand year. to compared you, period last in and very record year in for posting another to end-user call. demand also U.S. the good morning nine-month same in Scott, Europe record

of consolidated basis, sterling net the revenues the third revenues through Year-to-date, XX% the quarter in reported also XXXX, On the currency-adjusted XX% But due that were compared end revenue $XX.X to to but of representing year-to-date our million third the million quarter, approximately increase period over were negatively euro to same segment, million year-to-date. by $XX.X our grew our XXXX quarter reported was revenue third the In compared basis, reduced year-over-year. growth for rate XX.X% by the Our and approximately saw $XXX,XXX. quarter. growth. XX% U.S. $X.X to a revenue XX% for million was impacted $XX pound revenues British the we grew revenue a the exchange negatively quarter year XXXX, fluctuations. million nine-month $X.X third impacted weakening currency-adjusted On by prior of

as units interactions quarter of strong year. U.S. segment our end-user face-to-face formats quarter for record units, with increasing customers on growth multiple to over drive third the last the focus a we Our performance across XX% and continues X,XXX of third XXX of demand saw in

initiative guiding consistent Xx success within for with entire and broader cross-functional certain account. being drive regional rate a and on focused workflow reasons the In are sales key with program cross-functional driven with success this organization, the by 'XX collaboration. account accounts model and principles our program program, far the directors. finding in program, XXX-degree are demonstrated effort each our significantly The so the collaboration This base. our We as work is positive of this Challenge results has this it's performance at accounts a key of to serving one of hyper of growing

regions result, number by regional sales time we without beginning sales program teams. a increasing providing to five in directors initiatives As January of and respective XXXX, more to of on scope leadership of territories, their will allowing the the these while for our the increasing coaching sales broaden the focus this

from follow-on data of publications retina any to addressing positive even to next commercial the We ILUVIEN. enabling These of compelling U.S. year. data the data challenges intend are PALADIN data specialists. our well benefits to be PALADIN Additionally, team highlight ILUVIEN study the received more results and continue by usage and while sets publish throughout presentations to

when receiving in of at ILUVIEN, manage results their Center, also that results ILUVIEN be eye As fewer ILUVIEN DME diabetic shows statistically visual can significant achieve results These XX% better as a the Mansour, that October. the in ILUVIEN improve and burden PALADIN often corrected label. demonstrated that significantly health dose DME with further with injections DME, of retinal That improvements DME. used fewer thickness Medical mitigated patients our can Virginia benefit the the to presented achieve in is side reminder, reinforce single reducing Retina effect in therapies better support new NEW the ILUVIEN study. our with patients PALADIN study study XX pathway effectively the or demonstrate edema when received pressure acuity, the average. the PALADIN hypothesis of months that of FDA implant patients best and U.S. American intraocular ILUVIEN efficacy thickness required earlier macular treatment Director subfield well of the is of on DAY central treatment an Ophthalmology can proving study data and who in accordance Academy from Sam data data at demonstrated for by as a The Dr. that Conference used demonstrated

international third business. to quarter, in million product down during Turning $X.X year-over-year. revenue XX% reported our approximately We the

of $XXX,XXX. basis, by international our foreign effects by up materially was the period. international business exchange year prior the rate X% our revenue reduced impacted which the However, Currency-adjusted segment approximately over fluctuations, were reported revenues

prior overall have international having reflect to Our but is over to been international end-user than slower year-to-date countries year, the our XX% with some results segment growth return strong demand that others. grown

all to return expect to growth countries XXXX. in We almost

opportunity a to strategic behind priority in ILUVIEN Our posterior indication non-infectious uveitis our grow remains growth. the

Over French nine the driving months, specifically. we first indication, non-infectious obtained six Spanish in for reimbursement our our countries market performance uveitis in European strong and

end-user in a saw international result, segment October. we in monthly As demand record our

sales for indication our that to continue sales growth fuel segment. will expect We international the of this

patients to visual with in to implant, for three forward or patients injections year, undergo the ability injections. DRCR we solution with will recurrence Network choroidal complication. at receive look of sham begin This ILUVIEN for for reduce risk for radiation DRCR emergence patients if their anticipates AL each therapy or the corporate initiatives. treatment and be to The we significantly can quarter the study radiation labeled the or in to find arms prevent Turning this therapy macular occurrence of acuity to condition. of radiation of edema. anti-VEGF melanoma monitored and Protocol Network. primary AL XXX associated the prevent anticipated agreed Retina treatment with Protocol to to will The anti-VEGF an study study best is arm for the ILUVIEN's participating next the first objective across determine enrolling that of is loss In ILUVIEN Patients retinopathy. Retina September, retinopathy either In will study, repeated treatment

landmark clinical Turning study. to DAY our NEW study, the

patients injections for more of of We all to XX% as current the necessary demonstrate better continue diagnosed head-to-head with reduction with against significant lead frequency now a enrolled. than and standard benefits the patients baseline long-term ILUVIEN in to This enroll is trial therapy objective outcomes. DME, provide care to the of the

caused enrolled during study liked for summer now months. a care rather due end in this we would the as completing than shortages XXXX not in to patients U.S. the have the bit of slowdown We of enrollment early We as the staffing year. in the anticipate part health fast have having

is primary now the quarter to for billion the treatment care study call ILUVIEN formidable a to of the of $X.X to that, over NEW I'll will the And standard a review financial competitor and results. third DAY Phil we opportunity revenue believe greater objective Assuming with become that significantly our turn trial Alimera. provide met, DME

Phil Jones

Rick, hello, and everyone. Thanks,

quarter of year. consolidated the net During XXXX, the our was third revenue prior versus XX% $XX.X up million,

markets. an Net quarter XXXX. which in in of XXXX of the from to third that to shared, due dollar was of exchange demand, to rates, was by increase The end-user XX%. in third reported units of was to the our mix the previously the impacted the account by the X% X,XXX approximately third the third decline XX% comparison. impact represents in $X.X rise million well The Taking million the On of a from was decreased our XXXX revenue European of $X increased quarter the Rick in the negative quarter in we net quarter compared U.S. to pharmacies was $X.X impact for quarter. XXXX. distributors, from physicians growth revenue units and fluctuations. international the across from $XXX,XXX end-user for our XXX our the purchased currency from the as XXXX, foreign revenue in primarily quarter basis, third quarter revenue third the XXXX revenue $X.X as in of international million As reported negatively exchange relative million of XXXX XX% U.S. the U.S. growth given XX% our foreign units euro the impact currency demand currency-adjusted the into segment approximately was period. revenue net quarterly

we end-user in the of of were from of up uveitis. recovery year-over-year and third consolidated quarter increased and million expenses driven XX% latter XXXX. XX% XXXX by an accelerate the the The in as in and Importantly, medical to compared expenses part office an Total from demand non-infectious operating the business investment ILUVIEN of of international utilization medical was the to $XX.X to given quarter XXXX, program the reported million $XX increase third the for intended by approximately COVID-XX increase customers increase growth higher COVID-XX. and in promotional were anticipate operating recovery procedures our the driven

third and increased quarter to with $X.X of in of compared million engagement an DAY study with We the QX we research, an and loss in adjusted associated development expense to increased million Additionally, saw in travel loss $X.X adjusted medical EBITDA XXXX improvements, of product costs related XXXX. affairs reported EBITDA clinicians. NEW

average for net diluted of million series income to and Alimera structure given the adjusted X to had cash of that to flow. neutral per $X.XX average cost outstanding. have savings achieve per shares campaign. of $X.XX initiatives of objective. $X additional costs in basic on all for close the of weighted eliminating environment share XXXX face-to-face third of cash XX, operating announced XX, rationalization was third actions cash realize believe ended We quarter in compares flow. by total million was limit per cash cash September lack to to to initiatives expected to this up expenditures decrease $X.X With improve weighted XXXX. annually, XXXX, net costs XXXX compared year equivalents expense reduce ended $X.X we as the have reopened health equivalents prospectively, the our September focus and save XXXX. and implemented. and savings programs, costs certain undertaking an rationalize in reported and the we three of the approximately XX, loss plan X.X on months XXXX, XX, After of Basic million compared than $X.X September current we of cost outstanding. shares For capital million a our million a loss reported for we net that public less three months cash June cash loss diluted net share markets, on quarter a million million $X available million care our approximately quarter the million million the the advertising to On and access renewed an generation of and to macroeconomic customers, the per to $XX This operating decided XX% After we we our such that external operating fully now are approximate this operating to for with organization ensure QX, our we are that interactions will when direct-to-patient EBITDA taken a can The positive announced fully in number and of previously we initiatives of of positive $X XXXX, on to annually $X.X further

to Rick. while next XXXX, I'll offer ILUVIEN back focused report more We business cost through financial quarter to are pulling becoming our We over year-end will call on our grow and with enable year. guidance believe these And fourth savings continue earnings on to to which results EBITDA-positive. in when details sustainably plan turn the our us we we outlook and that,

Rick Eiswirth

Thank you, Phil.

across our very are with pleased We demand the growth year-over-year business.

of now increase to operator for the remarks. utility of And our face-to-face practices due to the trial achieve EBITDA focus year. ILUVIEN's beyond radiation our customers growth believe our complement questions. is over the paying the evaluation on specialists their expenses progress -- to more I'll visibility benefits the we DAY rationalizing our We positive off and as prepared are retinal are the evaluating Our of sustainable study continued in ILUVIEN NEW therapy. retinopathy more adopting with upcoming to That interactions in to retina initiatives, this treatment disease. will in call concludes and our committed turn the operating

Operator

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

Alex Nowak

past thought sales Rick, risk bit accelerated the you or has we're the you're in What Company we or decline to decrease see not cutting that has necessary as investments it to a see program? we the future the because the is couple years? the next of going Phil, growth. just programs more quickly quarters, it now accelerate And was maybe that as a of been here the sales year spend to direct-to-patient over sales some just the beyond grow on in start as expand

Rick Eiswirth

Yes.

So think Alex, I sustainable. it's do very

to we think on doctors, cut face-to-face what really more with that the feet are ground, right? the on sure sort physicians, the drives going that focused is not the the engagement anything the be frequently, doctors street, going So we around are forward centered that with that have of the really being the are utilization. dollars very We because are engagement that's related to the hand-to-hand making on things combat all the

we the we'll think we plan our don't of cuts team. money plenty any So, have still in spend, of to field and structure

we with goal make to group. like fact, all in In the to those those the at outset formats, relationships we things protect continue to the that, did programs advisory a like doctors and educational invest just is board to continue sure of pandemic maintain people, as

So as year. alluded we our this some to, Phil do European restructuring operations in did earlier

and to than the the reasons eliminate You program quarter, things do some that see running severance going one through are of which like the the the we is of were was more costs -- wasn't or very And patients physicians of We successful going third DTP in higher generating think normal. impact it's some forward. money awareness engagement down physicians while think shut good, but is face-to-face impactful around the powerful. the and do with offices access the more and spend as and we to that that

Alex Nowak

guess QX strong for year all let's about as next That very say, this I quarter sense. Okay. you. makes year, you QX And is -- a think well, seasonally

about the flow-positive, business XXXX? rate that So cash be you think cost run see seeing you're at I'd what sales a maybe But what the quarter. in on on we side, flow-positive Should to some do around going expect you're what flow-neutral, seeing the cash to cash to based make? that you're maybe expect

Rick Eiswirth

Yes, do you that will positive. us be I I think XXXX, do. cash see flow-neutral in to

we standpoint. an million If you expense get from down operating expense projections, just quarter look the $XX to a projected below at trying

and cash moderate takes we that certainly of flow see standpoint. been math very the You and what do level to growth less seeing expense be growth than a positive can from it that have only at

able conservative flow there, that think cash we're drive we'll we very year. be next to and So, positive being

Alex Nowak

on of to Are a about XXXX. to around additions? rep it are going really just moved force Or around the new how ramp Okay. straightforward? territories? there at the reps? changes for be sales beginning be structure thinking time And Just expand Are going reps the for -- disruption, any more pretty different is bit maybe to you new

Rick Eiswirth

there's to there. territories. We'll field disruption have directors from shouldn't No. XX no actually five. going -- We're four We're roughly just be any to the change still There territories. regional

gentleman per to of regional the this on 'XX to schedules in director sales is we in can that's training accounts, year, cross-functional or has director director regional has organizations accounts U.S., the So to seven ran think to really fifth internal I'm focus U.S. flexibility global tried Challenge little reducing the in expand regional six, a a focus bit been XX other director reps those five really around we're promotion. key a that actually XX was the from us, that allow sales eight So in It's next effort to in program team very, right? for entire XX team more regional that year. pleased run control very span our We And that we and to familiar an past. to XX and to accounts. the

for So fit there. transition of team the our be and as lines perfect sort for seamless reallocate us, very reporting it he's a we should a

Alex Nowak

maybe throughout Okay. increase month can see it impacts and QX. makes happened demand Typically, FX didn't sense. in like end-user you talk whatnot. sequentially month It do look through happened, And all the excluding what That by we QX?

obviously, November? like in balance into the line what October, sounded far but October what so seeing there's pretty in you And the the And just are went $XX in on just So sheet. it in then looks market? you million current seeing good, debt are then lastly, that

long-term debt? reason covenant Or for that the was was move curious, what the tripped? Just from current debt sort there some was of to

Rick Eiswirth

Yes. Sure.

little with to had be So August. bit QX was a inconsistent. had strong record We a July. We you, a honest Alex, in

in September. August a Company. -- dropped strongest And strongest off it bit history the I in think August ever the month had the then little in of was the U.S. we've

are is the are things phased doctors are we sample samples switch the trialing steroid. through to -- a we do shot faricimab are we at there over the bit being in anti-VEGF And seeing the a Vabysmo of little units that marketplace. that One one more in or they think there before faricimab a is lot few patient think there for out a of

a And a in samples pretty also there. they so cycle this month. of Revenue October up we there but may again, popped be strong of bit put out know little lot we dealing with back a

a specifically really now We if be difference may that to temporarily, there, to let we this anti-VEGF. We've our sample Retina a And they're Chief that perform, any we talk So it's there's faricimab. and doctors going that's try and got Specialist, think to, one got but through as of shot. perceived issue. cycle think the don't free stronger them a that a you lot giving

to technically, that of With So little did to I little bit impact is bit the think lender year. the debt respect solve forward. -- think We're impact that. lender, to a the third is working address as amortize starts to And there that listed of our be -- of really had going we'll who early the next relationship strong an existing because I having with on able the current quarter. a in a have debt, our we've process debt Solar,

than there a we've the our with think been despite talked is from really it's stronger of about today, as bit global it's challenges little business -- faricimab. I standpoint, ever demand

in are by the feel that manage the able -- the to good of we'll about with feel into work to and we ability good about So, be comfortable the end something Solar XXXX. real out year. real cash the going We

Operator

Partners. The from ahead. Laura Alliance comes go of next Global question Sorel Please

Laura Sorel

for is Sorel on Jim Laura Molloy. This

the for when And complete top what then the in particular? you retinopathy to for do trial expected study the with for look to next DAY line line an radiation Center expectations reported? next agreement with when interim following study, also commence the overall in And data regarding expect mentioned, early [indiscernible] enrollment initiation So NEW to be trial this overall time is year? as announced this of ILUVIEN Jaeb might be year,

Rick Eiswirth

Yes.

a I So it's while their years study, XXX-patient start standpoint, year. about speak think most so it will anticipated It's to enroll. to confidentiality two let DRCR likely lines. take to publicly that from enroll next is a for But And study, a we it the to take time them study. need going they'll

that So, the actually be the end With is respect is quite available. time point. DAY XX-month some data will will NEW it before -- study, a data it to

quarter, in completed the so, And by have enrollment have we the of then data would and is hope we first still XXXX. end the

Operator

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

Rick Eiswirth

participating interest have quarter day. for results fourth you. and Thank to and call I Thank report full and forward early a when sharing Alimera, ongoing everybody XXXX in your look our we year want we on and progress our great to thank today's next year. you continued

Operator

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

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Alimera Sciences (ALIM) 14 Nov 222022 Q3 Earnings call transcript