ALIM - Earnings call 3 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 Third Quarter 2022 (sic) [ 2023 ] Financial Results and Corporate Update Conference Call. [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. A webcast replay of the call will be available approximately 1 hour after the end of the call through January 26, 2024.

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

Scott Gordon

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

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

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

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

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

Richard Eiswirth

$XX.X million YUTIQ the up of increase $X.X of field quarter X,XXX saw quarter XXX% units of an over of grow quarter for increases leverage revenue X call. force an $X.X our and sales ILUVIEN and end-user significant third opportunity X,XXX achieved earlier moving demand approximately We behind net segment, everyone we we the there excited I'm to the the of with created to brands, YUTIQ. sales results, reaching expanded quarter morning in XXXX. ILUVIEN of this XX% units, portfolio ILUVIEN demonstrate our products third YUTIQ the U.S. growth demonstrate by net user to QX last and -- demand over sales growth significant to growth third personnel. achieved of And positive and adjusted third year. We which to quarter, year-over-year. to is Scott, increased of driven million million, with YUTIQ quarter. In year-over-year. in continues EBITDA you, U.S. the increase a our detailing returned million to record importantly, end XX% and the believe X% $XX.X good year, the in both by other additional in adding both the the our Thank our quarter share forward on to revenue contributed

team, all team, we shared We're in over and represents detailing reps increase new detailing taken in who began products As in August, learning XX% still over our curve late for a the an which increase reps larger our both in July. a ILUVIEN XX% promoting YUTIQ product. on have in

increase plan further is products education in both sales to in a the very and with more employees and knowledge field July medical for to field customers. our training our value and And their meeting follow-up launch Continued success. in We to September. held all we the provide continue to important training to to

the is because X cross-sell get use continue indications. products opportunity we better believe only is I product second many physicians to this X significant today. there think a we to And will across that both the to important of

forward. a the YUTIQ significant quarter ordered ILUVIEN. third accounts us only and both third the or ILUVIEN, quarter, XX% creates in moving YUTIQ the example, of in This either ordering, opportunity For for

and markets, International of our we year-over-year, We European XX.X% to significant third performance In driven our user saw million in a to by a direct XXXX. quarter, over approximately direct Germany end of our demand markets. net of return strong $X.X segment. growth growth XX% during revenue an in continued reported increase the in Turning other QX

However, segment down caused rationing end-user quarter. X% quarter partners stock by for demand the in the International our of the distributor by was during

have to expect strategy, the as our manufacturers course in month. were distributor investment have our We're Operating in distributor As you have has already previous seen, with Officer addressed Chief improve of development with significant early do experience ophthalmics roles in partners may levels corporate extensive an who is working and in we levels. We and join year over to pleased us Jason in stocking background commercial early last increasing Werner, the Jason QX. QX partners to this our improvement inventory next and area and at

be ILUVIEN to expect with continue of a we driver. the sharing As that discussion we YUTIQ, and pursue will additional data utilization increased significant of and physicians the

set our day the treatment of data outcomes, improvement to including excellent believe new control variability for continue PALADIN reduced marker outcomes. thickness visual and an We that is study burden retinal in

and the months. a macular burden corrected single that at acuity, to in ILUVIEN of a study treatment edema demonstrated reminder, dose received visual demonstrated improvements statistically best As PALADIN patients XX diabetic central subfield significant with thickness

label. This used can side presentations at Retina X its Society, that meeting EURETINA is well of this And X risk effectively in As we an in with at alone, when the York, we demonstrating ILUVIEN of be had effect, the the pressure data. FDA month in New accordance additional intraocular recent had Amsterdam, mitigated as presentations.

demonstrate another YUTIQ. and posters of a clinical Ophthalmology this Next ongoing study. From from in X further ILUVIEN the safety and standpoint, several Francisco, month, have we the designed trials and to presentation efficacy American the will highlight of ILUVIEN of at Academy effectiveness San

in utility anticipated the data baseline remains leading Our of enrollment anti-VEGF XXX first of over-enrolled of edema NEW macular quarter versus DAY has on diabetic the study top the patients evaluating ILUVIEN's therapy in XXXX. as with treatment head-to-head completed track and line

a a and evaluating an the study with efficacy clinical eye enrolling which efficacy prospective interim safety synchronicity of anticipated actively segment of open-label intraocular quarter X-year associated We XXXX. and posterior the readout macular X-month of is within third treatment This for are the related inflammation. the in patients line in study, YUTIQ top chronic the is study our edema affecting of follow-up uveitis noninfectious

we've eye. of in the completed YUTIQ to collecting Additionally, the YUTIQ data registry Cleveland study a for moment Clinic, conducted The with eyes. the noninfectious treated CALM study is study uveitis the understand real-world of the posterior with with better variety conditions XXX segment in affecting CALM a collaboration

and with Network the the to are in Protocol to AL. ILUVIEN, working DRCR we on cohorts with We individual be support medical conferences outcomes Retina expect combined patient efficacy presented XXXX. Also trial, prevention at AL either due injections Protocol visual is intravitreal observation for retinopathy faricimab a evaluating radiation randomized to following versus loss radiotherapy. acuity implants of intravitreal plaque clinical ILUVIEN and

actively in to look patients the broaden financial of months. And the evaluating that quarter or future, third either are the in forward with implants further the detail. results indication greater number to details to turn steroid update, we expansion YUTIQ review our ILUVIEN treat. to Russell that over to long-acting help sharing We coming as opportunities Looking can call I'll

Russell Skibsted

period of YUTIQ units into increase up International increasing million our year. QX growth end-user to The quarter the received $X.X the U.S. net very was more sales to QX in QX quarter XXXX. the of $XX.X the adjusted last to U.S. over with third well, operating markets, the in to than X,XXX combined the the sales hello, XX ILUVIEN for Rick EBITDA down amortization and increase well during operating the the of period segment, quarter last were year-over-year was to, Thanks the $XX we million compared The in in was U.S. for in due demand associated million and expenses I YUTIQ X,XXX 'XX. to million where year. depreciation acquired. same Net with over YUTIQ costs for approximately during in loss QX of was the XXX last international the addition in both This in last to revenue QX units reported also to $X.X and $X.X $XX.X growth the to third due our we units in 'XX. over 'XX. QX units was year. period compared sales to with This increased for up $X.X same receive We $XX.X for XXX% portfolio, which revenue demand our higher ILUVIEN units EBITDA compared and as same direct X,XXX the up in X,XXX approximately the International markets. Total to for and of units units end-user was the $X.X increased the quarter This X,XXX in performed demand YUTIQ. U.S. 'XX, units U.S. due record growth of quarter. million addition organic the ILUVIEN which happy attributable the approximately to year. Total approximately $XX.X to adjusted as and XX%, addition net in in during This X,XXX in units XXX unit. XXXX, was joining was in everyone. alluded YUTIQ in the U.S. million revenue million an associated to revenue million compared increased $XX.X net per the also revenue quarter 'XX. million ILUVIEN million primarily XX% for for period same Rick, to last revenue am as approximately end-user of assets today. year. Growth was the report to million of ILUVIEN that Thanks, us almost net

terms paying collecting primarily we the September $X.X of million quarter. this of in because compared XX, the a during YUTIQ month. expenses the was the equivalents $XX.X to 'XX. all made but quarter this that during is we million of June did began on of the cash begin result we the investments burned payment Cash those required As until support addition cash of not of we XX, What approximately had YUTIQ distributors, with to May, that on for capital XXXX, working and sales means

of generate hand comments. in will his positive call can the fourth the Rick quarter We he so give that, and closing 'XX in Rick? to over now I cash expect XXXX. With flow to

Richard Eiswirth

beyond commercial commented year. to achieve Russell. sustainable positive are call last leveraging Thank on EBITDA our you, we that U.S. this to I our existing infrastructure committed

quarter This is that evidence strategy our working. solid was

We utilization and are XXXX, and of to the specialists, cross-selling our growth both having broader our we to support engagement opportunity both by committed stronger and look leverage team significant products leverage also retina and indications commercial X will the to drive provided revenue position by to opportunities financial presented with ILUVIEN products. YUTIQ. In and increase

opportunities evaluate noted patients. long-acting expansion earlier, will implant steroid for indication we As more help our to I

next goals $XXX our the was reiterating revenue and adjusted EBITDA foundation generate year in quarter million This first achieve next more establishing least step $XX million to at XXXX. and in than expectation we a in are to of our year

progress remarks, update the and the turn planning with our to to and guidance call endeavor a through EBITDA our will We as for the now for improve revenue integration XXXX questions. over these concludes targets. This we goal I'll and prepared operator to

Operator

will Thank Instructions] First you. Alex question be [Operator Craig-Hallum. Nowak,

Alexander Nowak

Good morning, remarks, for prepared the that here. doing cross-sell by that That go call everyone. number the XX% end year. realistically in where of Thanks the can the mentioned you

here I combination a metric important X of as think that's assets. the you the really complete

Richard Eiswirth

a will we took mean point products. both really X over I the I it's that's since to up hard or mean I project. one a Alex, say

see early, impact to but cross-trained So the products. next we strides certainly year to both I across of major we wouldn't get that continue I think there as really expect you're team entire into well until some get seeing

Alexander Nowak

see that's up. place, to number trading year of in next start all climb then that we kind The with can

Richard Eiswirth

right. That's

Alexander Nowak

such fashion. little a OUS I on remarks, there. quarter-over-quarter know expand in during the decline you on touched surprised dramatic OUS bit units seeing Maybe the prepared I was it weakness but the a

expand what quarter? over the was in happening Europe on -- in this Just

Richard Eiswirth

Yes, sure.

year the was about Europe. of year as than last in a So increasing in partners bit forecasting That's have markets. in and long some from late of we a early time have bit product first the was the we other -- lead a demand part in frankly, second we call, and talked And the of our manufacturing. been factor the distributor the for behind just expected, lower on supplying little distributors little quarter a

really pleased demand the growth the markets. we actually were direct in So with

if to that up over have markets noted, happens stock out XX.X%. think Europe some ration in units were so go is of of we they low What the XX%, on they the As are don't I stock. going in they out they

position. regulatory authorities, on each in-stock based maintain to partners just things out with And that to, the number had in shipping in specifically units lower an has so they're working our France the some order quarter of

And that. so mean I that's by rationing what

a built do as stocked the we're where significant to rebuild fully expect have were closely think back in course to to before the that back levels we be QX. we'll at up. of prepared is their comments, So And with said fourth them uptick they'll my stock the and stock to quarter working be once point they over I in

Alexander Nowak

regards past moving the had over couple choppiness sense. essentially U.S., With trialing the we and rate makes the to with was new drugs, they're That that of some ILUVIEN. to that quarters in slowing docs

to trialing like longer-lasting assume? on thoughts the thoughts that docs VEG -- are there. reversed quarter. retina drugs, drugs It on has this Just docs fair trialing, Is seems are anti-VEGF how that new out

Richard Eiswirth

a the is tightly therapy. trial faricimab It's challenge there's go It's is a receive a forward. patients and out that are there need isn't trial it still the bit spaced to drug, class they that are think saying as us demonstrated in very in reality it that they little of is is reality something patients I faricimab But anti-VEGF think of anti-VEGF Yes, than and is doctors therapy. that it. doses anything these everybody -- been is out a there as more right? DRCR the -- mean, I neat, And even anti-VEGF recurring we I there learning formidable. do of -- protocols this persistent edema of

But that. the of I there's think anti-VEGF now. through still a in place patients. steroid But work the of for use is faricimab need will aggressive the pretty we to So certain still take those

Alexander Nowak

then And questions, just X can. more I if

the one think NEW I for YUTIQ first on know on the study, X the as a change studies. ILUVIEN. how are differences outcomes little start confirmatory Or all bit a Just between study same we those expand studies? would DAY it more these And can Maybe just NEW that very is that's the in the how market level there, -- the to adoption like DAY? important

Richard Eiswirth

Yes.

with So I'll CALM. start

So CALM use uveitis. is noninfectious in real-world the posterior treating a evidence registry study YUTIQ to collect on of

One cohorts the used more talk hopefully that CALM where to effectively. studies get ILUVIEN or an And to as and right? at anti-inflammatory be treated were probably XX year. There one are that that no and the papers So look there consensus in is different uveitis steroid of would -- to should hope defined of of the about of idea challenges Europe in of of where some are specific more a guess, out next acting of produce to applicable we study. long-term more coming also pivotal And some locally we'll types well. there's XX types the the was cohorts of to able out the be And steroid that specific we types specific continue specific the uveitis. I cases back of the of uveitis studied is eye, types develop to some

evaluation in is really I help to uveitis similar pivotal synchronicity it will is studies. doctors very, earlier -- identification patients. in think of study it The very their those patient with So the

is more focus traditional retina the that and treat doesn't the get of the specialists referred may the However, type specialists. uveitis out that they uveitis to around

that, vitrectomy of physicians referred specialist. a that surgery patient right? lot is a characteristics surgery to example in result of maybe that, when retina direct uveitis a at there with of one times cataract is are postoperative look inflammation, So and that that's post-operative inflammation of And or

uveitis, of typically specialists. I maybe to because going is severe types present the identify where situations those some is long-term that a to of retina those eyes less as they've the or inflammation just type said, developed be it's types by in sort treated so of uveitis in And

Alexander Nowak

Very helpful. Last question.

You adjusted to guided EBITDA. $XX million of

like confirmed target next QX. that you're for year? do that morning But at begin again up this run for with start XXXX. looks in that rate You also to almost we When it to

Richard Eiswirth

in very there of could that this capital want getting we're of conservative label potentially I Alex, indications. QX to places very waiting of a -- that some through We said. working to, spending the in the for the doctors work other the sure are XXXX We sure the think and lot where get in as to on integration make we make we to some of want year. integration, as are progress opportunity and of in do pieces year some have and the guidance. we effort next opportunities alluded Russell expand been rest plans update looking before made do for we next at cross-sell front some maximize we with right as said, our I I As turn, to well bullish as do but to there we of

now, over right but year. and move that over So $XXX we'll give million, $XX million you next we on with stick going we're updates to the as into

Alexander Nowak

for the Thanks congrats on update. the progress. Appreciate all --

Richard Eiswirth

Thanks, your Alex. support. We appreciate

Operator

Next question from of H.C. line of will Chen Wainwright. Yi the be

Yi Chen

add is, plan XXXX? additional My do first to reps throughout sales question you

Richard Eiswirth

That's good now, Yi, thanks. X out months to we having Good X a morning mean or into the team there. only I of you. right are question. XX

So sales made rep on face-to-face this and see positive potential first. productive at to will benefits they force. evaluate Obviously, continue that how if XXXX, effective we I level But in time. more does to decision want think we the time no at expand yield the has are the to been

Yi Chen

comment your direct the represented of force? you percentage international by could on sales And revenue that's

Scott Gordon

of to Percentage-wise sales. our we're is say distributors of our I'm direct roughly X/X looking international going roughly is X/X -- and at total

Yi Chen

internationally? you the And terms in in either any the in quarters, or coming YUTIQ of expect seasonality lastly, U.S. do sales,

Richard Eiswirth

the related these products. going are seasonality high-priced continue you're quarter to to first in -- both to think I Yes, have

over the deductible January of slight of plans insurance X the or modifications vast in start with patients plans. years in majority new insurance their U.S., their as So

doctors investigations the always make me, coverage we see benefit February sure to So or delay a quite to and January insurance there. in excuse try as redo reevaluate, is

with that's think higher-priced typical I products some in space. pretty this

of season little the are You reset in the holiday see to in seasonality seems then European also QX some holiday related seasonality as as also well, well. do often they U.S. quarter season in first also of quarter, in in budgets their see Europe a budgets. And third as bit reset the the and impacted we

Operator

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

Laura Suriel

Molloy. This is James in Laura for Suriel calling

breakdown So this for what's and your both product net revenue the specific million, between YUTIQ value ILUVIEN this reported of $XX.X quarter at past revenues?

Richard Eiswirth

think Well Russell's that's comments, noted about YUTIQ. from of I we in was he -- that $X.X million

Laura Suriel

then year And next million mentioned how this both broken you ahead, that that U.S. also looking to $XXX guidance XXXX. provide be on a in in you're deliver again between Maybe just track internationally. would products, both and the more for bit up revenue on over

Richard Eiswirth

really As we our on plan acetonide and noted the the report in the of comments, going fluocinolone basis. forward to release is franchise a combined some

specific break the going the very we with on -- benefit a in low-dose steroid promotion confident So long-term I out But we're that. any not we're where to million out that. focus the indication. from would number. of working of still extra frankly, increased guidance And we're usage $XXX on mean, overall, be

Laura Suriel

quarter just on to this now lastly, the number comparison bit million your million. here share XX jump provide a more this at And in the Can then past past detail second X at for you count quarter. in

Richard Eiswirth

about XX.X million outstanding. common we're now, at of right -- shares We're

Laura Suriel

-- then And us. all question also from right. Last

trial on Protocol And out? the that you ongoing had? come data on into AL then the that Just look might a any first when just more updates

Richard Eiswirth

target, before this will DRC late probably they about -- trial lengthy fourth year -- We're of readout. enrollment see the mean It's trial. the that run the DRCR. a the patients. That's in a trial start on that's is it's multiyear any pretty you'd XXX in but being has the by quarter it's the I hoping

it's being run DRCR. yes, by the So

trial. So on we don't control that the time line

Operator

[Operator the Eiswirth Instructions] over for I'd like This to to Rick concludes closing our remarks. question-and-answer call session. Mr. return

Richard Eiswirth

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

Operator

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

disconnect. now may You

Alimera Sciences (ALIM) 26 Oct 232023 Q3 Earnings call transcript