ALIM - Earnings call 4 2023 | Alimera Sciences Inc

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Operator

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences Fourth Quarter and Fiscal Year 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions].

Participants on this call are advised that 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 June 7, 2024.

to IR, call firm. the like Gordon to now CORE of company's would turn over the Scott I Investor Relations go ahead, Please sir.

Scott Gordon

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

Executive will Alimera's question-and-answer from session in Financial Rick and Maltz, team Joining us, Officer; Todd President me Elliot Wood leadership and and the joining Eiswirth, today. are President Chief be Officer; Operations Chief U.S.

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

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

filed about For to the XX-Q, the as please Form in from Alimera's press factors with periodic or call, XXXX these Form to that December statements X-K recently this with well SEC filed refer year XX-K reports risks, particularly Form it. more ended today cautionary and XX, accompanies filed on described information SEC risk the the be most in release Alimera's as

include The to call time-sensitive Today's table will language information in that today, reconciliation a press see the or any this revise references after measure. that required is this events call adjusted of explanatory and is information EBITDA, any located update earnings occur publicly accurate to only Alimera's Except March non-GAAP circumstances as XXXX. content or conference disclaims X, to of financial release. which as call. Please by law, contains obligation reflect Alimera

Eiswirth. ahead. Rick, to pleasure turn go my call the to now is Rick over It please

Richard Eiswirth

strategic and our call. balance stronger we transformative and year Alimera. and transactions YUTIQ our obtain came it. than good commercial We strengthened goals. a morning exited capital the to and XXXX, simplified the XXXX a portfolio. was pivotal We sheet much for Scott, for many completed In our Thank rights we expand into We XXXX product structure. accomplished to everyone you, on

the flow We the as mass our both XXXX. and team in commercial adjusted drive moving of increased expect operating in to both clinical and of critical growth established IV Phase YUTIQ positive EBITDA ILUVIEN DAY drive we will SYNCHRONICITY expanded future utilization and and both forward products, our drive enrollment utilization We cash that studies. years. we completed well as to X NEW in

for to patients benefits As be expand transactions the technology completed and we with YUTIQ into serve XXXX. acetonide U.S. available implant acquired see of conditions. We rights to head to retinal we the XXXX, the in us to consolidate these fluocinolone indications the the

of and ILUVIEN utilization. there Now the have the XXXX, utilized long-term products. that patients way the of the to delivered legacy we both product. U.S., we In the durability physicians and increase patients allow selling sales is opportunity in our expanded consistently and a want and ILUVIEN U.S. our opportunity believe of broader With significant the YUTIQ force to marketing We our low-dose in that to fewer their YUTIQ than that our both same of today XX% learned YUTIQ ILUVIEN X and physicians we do in that indications accounts is tremendous. provides at both technology believe

pro to the business, XX% progress global of XXXX half both indications. year, training We $XX.X the with promote We and our XXXX. grew the of net in on million. forma of incorporating second back the XX% and net XXXX, to YUTIQ of products QX significant over our the ILUVIEN X% results financial globally, second acquisition full up half revenue products of into And year $XX.X sell of over revenue our our continued for a The growth half over utilization year grew million. spent QX, In of XXXX YUTIQ commercial of have in improved to our the U.S. consolidated both XXXX our basis. significantly the team made

have we portfolio. operations Importantly, with we we from as a mass and driving projected, critical are cash positive adjusted larger that now EBITDA flow

Our million, a we XXXX adjusted million. fourth $X significant $X.X EBITDA loss when quarter the improvement in was QX adjusted of EBITDA an over had

in XXXX, the $X.X to positive For loss full $X.X of a year adjusted we EBITDA of of delivered million compared million XXXX.

a year forma XX% U.S. demand versus and net million the XX% million. for of In for XXXX our QX QX the a up XXXX. revenue XXXX in full million full contributed $X.X our increase in end U.S. U.S. user $XX.X $XX.X the in X.X% versus pro revenue This basis QX on to to year in prior for products year. was increased of XXX% segment, to

have Although commercial to Uveitis of significant the high-priority of YUTIQ indication, opportunity have we the us with selling great believe we and integration of we maximize benefits X made still a strides the products. ahead

of To session. Wood Todd be our U.S. and one business, successful with in great our operations. December such President help indications is joining call brand, the has experience XXXX, of the where believe a for leading wealth of brings and accelerate brands as U.S. indicator team ILUVIEN in us is BOTOX both in growth a We on possible Q&A Lumigan, what International the as the joined Todd will our our on

net for XXXX, million. business International $X.X full international revenue in XX% both year. significantly to and QX the In grew grew QX Our

demand increasing full in We and the quarter partners from end demand segment, the up year. also the Portugal, in the by user markets QX and both for net million. a full France. for year revenue Revenue distributor the of our user and the was end U.K., for driven Ireland, XX.X% our experienced Spain was up XX% International full year, growth $XX XX.X% in And to

were through demand after due second to second over not capacity, quarter. being able the year, supply we the fulfill half all limited end However, end-user up the of XX% to the of the of in

our and to Werner as additional Operating XXXX. manufacturing into capacity investments we made available Jason faced longer moving forward. be ensure Officer, we believe Chief In to joined Moving team We issues. make supply continue and these QX, no will with have

timely demand anticipate As significant in shipments in XXXX Europe quarter distributor forward. end-user we a result, the made manner a fourth in moving meeting of and

International We to a of of some markets utilization to continue uveitis introduced the in growing contributor we and have YUTIQ in growth, as expect the anticipate we positioning we be following the acquisition of those our business indication significant to U.S. the adopted the

markets the pleased us allowing International been When years Jason of to Dr. in Philip in U.K., the time focused of past was on Operations, distributor execution has to throughout direct and President XX of his our spend for I Portugal, Europe our and East. the the International joined partners us, Ashman, segment, Phil but both also who with Middle Germany, as name growth supporting of Ireland, XXX% the

Care ILUVIEN. a Health also for less as draft In February, the that patients natural issued has surgery, guidance, access the to announced chronic diabetic NICE the DME final Excellence, to National has have X/X than those NICE, population. U.K. lens limited or or patients, we with patients macular recommending Institute had reimbursement pseudophakic undergone and been which known to cataract only [indiscernible] as of is date who defined edema

our DME, for to reach base. have a the user expansion to chronic advanced potential patients potential we significant of phakic Now

to such half as XXXX. believe reimbursement this We positively in expect second this limitation and markets, a as decision of in adopted wider broaden This historically these factor the contributing U.K. the in that in countries as decisions. Spain to Italy, patient availability has look of reimbursement NICE NICE which our if base reimbursement will as well. guidance potential in We other the other in impact well, the the impacted utilization countries

$XXX previous million In goal annual that XXXX calls, YUTIQ I've EBITDA consolidated to in revenue and the shared XX%. margin following of was our achieve for transaction

As exceed financial the with for a XXXX, we an $XXX of revenue EBITDA of to for success our half result second the million in in of revising XXXX adjusted margin are our year. XX% guidance the revenue

the quarter-to-quarter seasonality deductibles lower our have dampens the business like Historically, primarily our new patient of with in do of year of ILUVIEN we in fluctuate and the revenue utilization We high-priced YUTIQ seen January resetting to from which February. business. products expect resulting to and QX, insurance due

the as quarter, confident EBITDA result this XX% deliver XX% margins been to seasonality, to same and annually. our has in are year. would we quarter-to-quarter but XX% this also of QX a we Historically, Adjusted QX ability of in the anticipate below revenue will fluctuate impact previous

baseline to impactful near-naive data early also provide completed believe in enrollment XXX drive NEW ILUVIEN as finished DAY a physician are enrollment and NEW have pleased a or patients X versus of head-to-head naive We in study in leading will we that the anti-VEGF Phase patients. study therapy landmark utility study edema. in with macular diabetic utilization the studies in June, increased is we IV our In future. DAY treatment the evaluating The and

successful, believe moving long-acting corticosteroid therapy low-dose DME. comparison study in could is treatment the treatment we for anti-VEGF patient first a paradigm implant This if the the change And by DME of of long-term journey. in the earlier head-to-head versus therapy steroid that

The uveitis edema prospective we the January, completion YUTIQ with study, evaluating year last noninfectious is clinical projected announced affecting last enrollment safety the related visit study the segment open-label having interocular XXXX. treatment eye In of and of we of chronic the SYNCHRONICITY inflammation. patient, the posterior the this is and for QX in a associated of study for data macular in the efficacy and early of in anticipate which

clinical boutique study in This general readout of X-year solely this to opposed anticipated practice with as trial. a the retina follow-up a is top X-month interim half is to who in year. uveitis line by practice YUTIQ in purpose study's second This in gain specialist real-world insight broader the an use the efficacy those specialists

update, fiscal our that results call I the and fourth with to will to greater And financial in detail. quarter Elliot turn now review year over

Elliot Maltz

at I'll a pleased up numbers financing continuing in in to time compared revenue approximately million was Thanks, you and discussions then you QX exciting $XX.X XXXX joined with brief forward update. to take . Consolidated to I'm such XX% give QX have XXXX. everyone. million $XX and net hello, all. Alimera Rick, an and through to look very the

revenue approximately operational U.S. End-user to our fluocinolone XXXX, forma a in increased XXXX in was up segments. XXX% units which XXXX basis. QX $XX.X $X.X X.X% for million on compared to the in pro X,XXX QX is Looking net QX to implant in at million compared QX XXXX. demand our U.S.

by XXXX quarter. X,XXX $X.X was about of in double demand that to inventory increased our was are QX in results. of approximately XXXX to our QX to in primarily Spain our in distributor in international end-user markets our shipments stocking revenue Total The growth $X.X XXXX. International XX% million QX France and our increase during direct driven to million the demand down net and due more end-user units, XXXX QX approximately limited is to XX% International compared markets distributors compared which segment than X.X%

half second the Rick However, has the this of result of noted, limited in as a prospectively. addressed year was that supply been

looking one, driven increase approximately at primarily consolidated in the full revenue to segment. in the XXXX, XX% net in approximately $XX.X increased million the the was XXXX. States our attributable year year to: two, XXXX Now throughout to compared million $XX.X growth of United acquisition and strong YUTIQ in May; International The in

sold U.S. continued growth France compared our growth of in in throughout as net European and to where specifically well directly, the YUTIQ and million million We XX% to international revenue approximately sell in to is in in notable revenue as Spain of well where net $XX.X XXXX million markets XXXX May Portugal ILUVIEN. million $XX.X acquisition in year In to segment, XXXX we ILUVIEN the Ireland compared to increased as saw distribution International U.K., partners. the increased approximately $XX.X XX% the ILUVIEN $XX through XXXX. the due as

X,XXX segment to X% demand up compared International end-user XXXX. units X,XXX Overall, in to units was

of of impacted for charges negatively $X severance expense approximately approximately sales million European was The expenses approximately XXXX the expense. $X.X fourth approximately at distributors the operating and rest compared debt pre-COVID bad fourth P&L. of in in $XX Total million QX related quarter XXXX quarter increase of by million XXXX. to our looking to of to Now in one our of were the $XX.X onetime million

compared an amortization from also the $X.X $XX expense Total with $X.X $X.X and to that the the comparing resulted in year million The approximately both prior operating was YUTIQ YUTIQ. increase approximately were from additional QX in XXXX. XXXX the XXXX staffing full assets million QX XXXX well to expense million year, acquisition. as XXXX. When million additional the is intangible and just expenses I approximately for mentioned was QX loss Net for $XX acquisition quarter the of due as fourth in XXXX interest of the million items there of despite

million $XX.X XXXX $XX.X For million was loss loss of compared in full year, to net approximately the XXXX. net approximately in a

And generated $X.X We QX of in approximately are adjusted million QX positive adjusted adjusted we to of EBITDA quarterly EBITDA. compared pleased $X million an the EBITDA XXXX, loss in approximately generating trend to of continue XXXX.

full year, an $X.X million adjusted XXXX XXXX. in adjusted we million loss of For EBITDA the EBITDA of in approximately compared generated $X.X approximately to

As lender, full of May met a will the for a SLR of year, period for This result our posting the interest-only we adjusted allow term trigger XX-month an in payments this start defer the EBITDA with important loan amortization Partners. extension agreement the Capital to and XXXX. of of have

you compliance of terms facility. other the as in the So with remain long loan

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

in cash position transactions XXXX. improved addition the In generating the effects financing adjusted positive our of year, strategic was by this to EBITDA

of year, to fees in our revenue-based SLR, and triggered in term with XXXX. December, As loans the this million the in remaining $X.X million we expect growth included of we result a $X.X revenue milestone trigger

continues And in $X the facility to working obligations. some great SLR capital impact the we a size grow in continue for cash. be loan order yesterday, with us increased additional the our the and operating This and to utilization million of of preserve more an ILUVIEN YUTIQ, defrayed flexibility we of of contractual partner. for provides to upcoming as cash

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

Richard Eiswirth

Thank you, Elliot.

future. financial and leverage we XXXX think great the Europe. the we've XXXX demonstration As in for mass the pivotal the I year in the our a was establish for U.S. of critical in with mentioned, to infrastructure YUTIQ, of of second And stability that retina half providing Alimera to acquisition space ability our is necessary built a the the

ILUVIEN beyond. However, XXXX a utilization YUTIQ in significant there to is opportunity the and grow of and

[ that force sales frequency with larger ] year. retina on XXXX as ILUVIEN critical physicians will we make that X and our being they greater specialists trained decisions. YUTIQ, to that and fully recall are the speak believe for provide full for We able more in calling believe promoting in physicians, often be promoting treatment in field We won't indications and value more and reach a with and

to YUTIQ deliveries We in considering long-term patients. as help the cross-sell believe customer, for both and products that carrying both will likelihood X of same our brands grow to the more bag were increasing we low-dose ILUVIEN able using both of customer benefits indications on the a

believe outcome conducted retina ability NEW the SYNCHRONICITY EBITDA numerous we've We increased of will a full reasons, world revenue are good YUTIQ XXXX DME. practice. more the and We the ILUVIEN for treatment we around utility And those million special $XXX use in study exceed will the our year. of bullish and XX% general highlight support the of to about that adjusted successful believe study ILUVIEN DAY for a an are for with earlier in studies the the paradigm with and indicator report the that in margin

the That over operator prepared I for remarks, the you. turn to our will and now questions. call concludes Thank

Operator

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

Alexander Nowak

the That as existing now, think I go for than transformational question to around quarter, just you here you cross-sell, Very could about within over much cited how retina at it's that the well? right next years? think utilization realistically can less there How first last can out several XX%. Todd, And What specialists? then -- maybe macro XXXX. XX%

Richard Eiswirth

first. So I guess I would comment

for First all, thanks comments. of Alex, the

First that of respect going to the I'm say cross-sell. all, with to

months we of don't only revenue. think drive the to that on if I to have internally other never if overlap you the next that do But uveitis. specialists want XX XXX% over get a going know do treat to aspire can questions? XX% we Todd, because that to in I number you You're population get there certainly, comment

Todd Wood

the crossover, Yes. terms different right? I Yes, focus because of uveitis, of Rick. looking going when We're get with inflammation little specialty Thanks and for in can the are a retina in the all to there's crossover of we bit question. post-surgical the and expand Yes, inflammation, Rick, it specialists we're they agree YUTIQ it But not postsurgical specialists. looking is there. at if the as with at uveitis get a

work We that. be a the in to So get seems to opportunity it's all of do number XX% with of But a get to won't Rick I but there's going that like little good crossover. agree bit to. it, for

Alexander Nowak

And we've market uveitis talked trialing well. in past, in then likely and the there the of DME the about was new drugs as

or more I the the latest on, for DME competitive Just environment what's uveitis? both out and guess, less there

Richard Eiswirth

Yes.

space last think half the another in seeing that the aspects aggressive. I pretty occurred second year rival. competitive seeing DME, are year the are the new you strong the competing was of of that into in a some of some with you of And entrant in second year, half sampling the

has So bit. I little us think a impacted that

But needs consistent anti-VEGF past, along, block that the comes with corticosteroid the although there's the in can the really be address. that a and when through that what patients the of comes seems in still trial we've treat to to there's anti-VEGF seen odd inflammation end, in our broader new

although a work to those So us. lose maybe we way of the for a patients anti-VEGF, of ultimately for strong through patients trial their period time,

Alexander Nowak

absolutely. study? DAY for the we line And NEW top can Yes, expect data when

Richard Eiswirth

toward last sometime in be The last fourth so the in first of XXXX. XXXX. second in quarter It'll the the patient, probably quarter, visit early end quarter, early

Alexander Nowak

And two it. then questions. more Got Okay. just

really rights here one that the you around, first global portfolio. the now to The product have

size additional thoughts return are line, on expansion indications, the R&D into indications? the What your moving this Just there? the maybe of increasing

Richard Eiswirth

indication places at where Yes. are as call we to talked said can and on think we last about Look, some do look expansion. continuing I we today,

years. that been for corticosteroids XX I think or XX using have

there are say have because And me they work, indications. heard other before guys right? that You

looking could DRCR we're radiation been doctors some with the retinopathy at we've where have other having advisory some the boards with indications we protocol We potential and at develop. looking that AL

DAY study the our would capital rather study than and see costs. big a we roll SYNCHRONICITY the off, in As NEW increase that redeploy probably

Alexander Nowak

It like on QX, rate with it. it? clarification for then lastly, the it high Got the now of $X interest XXXX expense. kind looks just is to expense addition assume in normal And million interest of for of Okay. the which top around the came pretty here

Richard Eiswirth

Elliot?

Elliot Maltz

take can that question. I

but with the million it, basis, on expect milestones ballpark, would that QX we do rate, we XXXX. interest with loan additional the -- such of million one because fee triggering around let's million payments our met in related SLR exit So typical additional $X.X to we a quarterly expense. was run $X.X agreement a contingent And adjusted $X.X triggered an of be of call anticipate interest this during

So we to and X expense begin do of interest will anticipate again the months that X to then first normalize. over the year,

Operator

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

James Molloy

-- And many -- message you at retention I forward? how if sort what has walk walk year? change the of through fourth the sort wondering was And with currently sort the all? resonated you through of the working over doctors reps year, other in And even that is how through best can and could the going if of does quarter have

Richard Eiswirth

Yes.

will this well. Todd, So as comment on

promoting within on and after opportunity those DME. to as go already OZURDEX, right? X can patients of especially has I for for us been the for talk uveitis well. while against and Because think uveitis now that that are for the OZURDEX DME indications that or where we Allergan lot big a us, A [indiscernible] easy are diseases, about

group and just there's of go can we border a there patients that assist. after so And

opportunity the will forward successful to in the await NEW we us conversations SYNCHRONICITY and So data I a DAY those data. and as be while think move continue we XXXX, for are

sort the territories about country across the XX have call, had We've have -- right attrition. We normal of, now. we we

sales that the We have decided some the people we to force. of have turnover in

have pretty that? anything culture We if we've half because had anything this always I like back to many team. we'll want you strong in you year or of too to have but have need Todd, people to here, sales I that not don't got know the go some turnover to competitors think a add that

Todd Wood

Yes. and and of Rick And advocates opportunity our differently use. said, they of when we preserving then lowering at the losing displace They add messaging, as -- a to view OZURDEX risk severe little the Yes. your and that, of link There's Rick. look some And at the I'll target. more our earlier, that earlier, competitively. to vision. we is product bit effectiveness the disease to vision look

really gets leverage we need it position So to the really treatment those then it, to clarify earlier and X items in positioned so paradigm. where

James Molloy

-- the Then the was maybe the in right. prepared comments G&A you fourth a housekeeping. All in touched Maybe quick the in already. jump on quarter? What Great. G&A --

Richard Eiswirth

in $X.X fourth of was quarter. [indiscernible] And items one-off fourth recognized expense of few about the one of There to pre-COVID then that was a events the we sales quarter. million European our bad million there's during related So severance of we the quarter debt $X distributors. another that during fourth that recognized expense

had the and to compensation higher things during G&A look stock-based you employees at balance when a result certain expense, we quarter-over-quarter. this which higher also drove Additionally, equity of quarter, an a fourth was grant

James Molloy

million Okay. It's of the quarter? about or one-timers in so $X

Richard Eiswirth

G&A, little Approximately in bit factor when a right you're in the but ballpark. higher you

Operator

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

Richard Eiswirth

very participating look and to a Alimera. continued sharing our and our interest you for much, ongoing when today's We late results have on all April. you. Thank for we Thank day. Thank support wonderful you call your quarter all first progress and report in forward for

Operator

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

You may now disconnect.

Alimera Sciences (ALIM) 7 Mar 242023 Q4 Earnings call transcript