Alimera Sciences (ALIM) 31 Mar 232022 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the Alimera Sciences 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [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 July 1, 2023.

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.

for and and call. Jason, morning, participating you you, conference in Thank today's good thank everyone

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

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

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

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

conference isolation as not EBITDA includes measures performance. GAAP. Alimera adjusted believes revenue, evaluating accordance in product this be consider for adjusted additional We that with net or its non-GAAP useful a in in substitute financial can results prepared should call Today's and information

reconciliation measures press most financial comparable GAAP Alimera's the to please located release. these financial see For directly measures, earnings reconciliation the tables non-GAAP of in

or this March that law, obligation accurate that time-sensitive contains as of circumstances occur update or required only publicly to after call. to today, of information events Alimera information content XX, The reflect as call Except any this XXXX. is by disclaims any revise

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

which past in U.S to company XXXX, was robust significant international very both to our pleased and in experienced driven gains Thank segments. I’m and user by morning this share growth good everyone our on largely you, call. this end Scott, revenue that year

agreement balance believe we loan and continue very extended sheet recently. having As amended our strengthened sustaining this a our to extend term our momentum just and in XXXX, -- result, well-positioned we are

and our delivering shareholders. committed building are this We remain to excited success on value and customers to to continue

reported increase demand of with XXXX by million, $XX.X XX% U.S end product We in growth, and XX% user and segments net respectively. growth our driven a XXXX global over both revenue XX% for record international

our COVID unaffected in end XXXX XX% was year the by to in user global In last pandemic. fact, XXXX higher demand than

to are we pre-pandemic to pleased very growth. have levels returned So of

Also growth by of million revenue note, deterioration consolidated pound, reduced and materially revenue the and by impacted the our euro in the prior. was comparison which $X.X approximately to of British

adjusted net XX% exchange Our periods revenue, constant grew rates product over foreign year-over-year. had reflects the which revenue remain

for non-infectious in Republic. the Czech continued Portugal our Additionally, we XXXX, expansion approval reimbursement affecting additional France, countries: uveitis posterior and segment indication our in and the gaining approvals five in Italy, by geographic gained Ireland, Spain,

being uveitis in impact saw markets We in these for patients ILUVIEN XXXX, our of in see in strong available indication launches and French of XXXX. to excited for and the physicians launched newly Spanish year markets are full we the and a

distributors in Importantly, which in our from we've our XX% shipments expectations all XXXX. is in of orders XXXX firm already greater excess to received XXXX, $X.X these for of distributors already high million partners, purchase than have as

continues hot today. burden, the published in manuscript Ophthalmology of XXXX, American topic very significant published achieved you peer PALADIN primary treatment business. be deeper for also In injection our as retina we a also which, The Journal journal to reviewed and We for dive milestones ophthalmology. a our of in the study into ILUVIEN reducing know, the value

journals And three we also peer-reviewed other submitted XXXX. manuscripts to in

cytokines DME that and that This of them, treatment that improving paper have has key like this vision. a and safety and and reduce only stable month expert significantly thickness can ILUVIEN of ILUVIEN profile chronic indicated in that being specialists corticosteroids action, that consensus manageable long-acting on consensus ILUVIEN drivers such retinal ILUVIEN while OSLI. its One of mechanism on as gain of DME, inflammatory prominent inflammation treatment group a is retina published topics a variability associated broad an burden low-grade the

We submissions the safety both controlling of value regarding of months to additional of and of ILUVIEN in look potential thickness manageability the two publication coming forward also the the the variability. retinal

the in DME. patients the baseline to clinical ILIVIEN the in of progress side, clinical enrolling naive in continued On our we study, as head-to-head trial landmark anti-VEGF our injections repeated over therapy and suffering designed near-naive patients from DAY NEW the ongoing of treatment demonstrate advantages

an today, study enrolled XXXX. in enrolled. patients XXX is additional the And of We as XX%

Trial with we behalf We Foundation, expect of and Center agreement for DRCR support into network to also Health complete study an the and retina second And the Job entered quarter. Research on the recruitment during to intravitreal acting Protocol evaluating study implants of ILUVIEN radiation acetonide Clinical as observation prevention for injections loss a due Randomized acuity versus AL. or intravitreal to The visual is known fluocinolone faricimab provide for also retinopathy. the

study for delivery consequent patients DME, dosing the reduce are micro utilized treated it anticipate complication delay ILUVIEN's the starting our believe We loss in with radiation quarter. therapy When its used as of will DRCR and for baseline we DAY retinopathy is second trial as vision and the NEW occurrence in continuous this brachytherapy. the being prevent of plaque

quarter who fourth review for And results I'll full over with now the the Russell, our that, turn call and year. will to financial

an XXXX. $XX net for the Consolidated from This million. XXXX we approximately that $XX.X was million of XX% reported revenue product increase Thanks, was Rick. in

revenue million constant year. Our adjusted currency XX% mentioned, of $X.X for was Rick the by during product On revenue fluctuations XXXX currency net a grew year. impacted the as basis, negatively

from with that million million a one-time Ocumension. XXXX That was Recall revenue should not in $XX be our revenue we XXXX revenue addition with and to our included that confused sales. in product consolidated revenue agreement $XX received our license from in non-product

XXXX by This full increase from up primarily in to U.S. driven product was end in revenue XX% $XX.X XX% demand. for million the XXXX. user $XX.X was the million in year

our the always fourth the correlate do users. end specialty demand with were than we As States 'XX, to due Alimera's not by GAAP In have end of approximately X% purchased of revenues shared, United in distributors. purchases sold quarter units U.S. to previously distributors our user more the timing

revenue XX% product International This But $X.X fluctuation from the in our $XX.X International currency mind, decreased to million from million recognition. in million keep reported year. negative last compares in our impacted segment period segment XXXX. the the same $XX.X revenue Net to

international So over have been on currency X% a constant $XX.X revenues growth basis, or would million a XXXX.

was million, approximately a deterioration. currency fourth the negatively the due of For revenue X% of QX over the impacted consolidated of adjusted $XX.X XXXX, to but fourth revenue $XXX,XXX basis, prior QX was compared quarter flat net prior On exchange our the year, quarter rate year. by was the to which up product

for was revenue which ago. segment U.S. $X.X Our year versus was a the quarter million, up XX%

to despite the growth temporary retina co-pay in some early Medicare we of space in we disease was all and U.S. fund unavailability expected in due to challenges, funds saw quarters these still other shortage sampling due and patients drugs temporary what in lagged for had shortfalls like chronic challenges Our in a The XXXX. of October. a impacted quarter. however, temporary faricimab Eylea associated the the with This branded also strong fourth quarter of the

successful from to we million was increase reported physicians expenses these change due as year-over-year we in in compared we the that significant the contributed were the primarily year. in XX% prior an were demand we XXXX. million, user the $XX.X pandemic. of $XX.X growth that in -- operating with investments emerge engagement our half increase Total as initiated saw of to believe XXXX We efforts to emerge to and end The XXXX from the second

in our that noted be more we our adjust expenses this our -- we our QX, In call, third to pre-pandemic in we in with a spending basis fourth on the quarter quarter began line go-forward tapering noted levels. to

$XX which XXXX. same XXXX quarter from quarter -- was down our expenses the operating prior result, a of year the X% and million, this the in down were As QX prior X% from

adjusted of to was the the year million however, in million $X.X XXXX, third EBITDA making compared an For quarter, we adjusted progress. are 'XX benefit of for the to Keep million cut in one-time the compared included $X.X of when mind, QX, the we loss loss $XX In reported our gain half Ocumension. EBITDA 'XX. so to a full

compared approximately 'XX. This that XXXX, September of equivalents XX, in and December million XXth million. we On reported cash of we cash had $X.X to $X.X

that equity financing, XXXX decreased burn, cash announced raised we cash our March million our position. this bolster we Monday also gross we will proceeds on As and our of in $XX

With that, I to will Rick. turn back it

Russell. you, Thank

$XX million our said to growth. our eliminating transactions future common earlier, global repurchase and preference. with Series demand completed success the that by very the I we believe prepare end company that strengthened We week. shareholders value significant of significant for the and we A We believe return As overhang the the in the I'm saw user real it last to of preferred our pleased stock XXXX, returns liquidation with we

to adjusted we pandemic moving and which we the have scale we And and EBITDA positive as of returned and facility, meaningful prior of the the $XX our cash generation adjusted flow positive allow XXXX us positive Russell and on said, to Entering forward. to continue extension generating EBITDA growth focusing at XXXX, -- raise XXXX. entered believe equity EBITDA anticipate the million debt in

And I questions. for the operator with to the that, turn will over call

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

everyone. morning, Good great. Okay,

The financial structure is around to, announced that just mark. breakeven of on, what this touch which here that week. So you I you're QX, we company in right saw you want earlier Rick, off recent left the kind around

capital that suggest could But be additional wasn't tranches additional pulled. new does also needed. capital the that some it So includes

is what new the So the point you capital? do blank I going with to guess question are

Yes.

right? that rainy couple just of for forward. working general leverage there's as infrastructure always in But the to to that the we want with we lender sheet we get a was to that things. think with built Alex, a we to I strengthen as some I cash the done you concert we we day, have did. have extension So balance the want move of have said, One, in because And -- also,

for consistent products We and to excited want that. in new Board a very bigger effort the this new for are the that retina to add Really and it period bigger have as forward. supporting we company very support mine move doing are us Caligan building both that company, SLR, is very, additional and philosophy pleased Velan investors think bag, our and new their in our we members look because to making those in of investors their I to ophthalmology lender with company, and

but can't So now, about our specific something find here. what to talk out built intention we right we to go is products and leverage there

sense. though, we now and spots. the are makes to products, talked push going financial bit I'm because has in the on just the additional company I different past, in know about a It little this a

be plan products the So whether preclinical, would understand with are I -- I range it now. all want these makes sense options or that about commercial there? the to clinical it mean why how you of add? be But early think to

quite mean -- couple there's of looked I right? things so obviously, of Alex, years. it's opportunistic, a at I lot Yes. over last the we've think

Some we passed of those on.

and we we we some frankly, of missed on. of Some have those lucky missed probably that those are

think to to would the the primary immediately. financial statement that accretive goal be be would something I find

lot So a gross we've Those generate goals. something be the that we the built. infrastructure leverage and could would drop margin really in initial bag, the of

in dollars think, things we'd development require opens up door that, be earlier find something with bag then we'd I other if then And frankly, developing stage development but dollars, for -- that can generating products first. we like will be those the that the

So the for an would goals existing initial something it's product to available but is find market. be that all or soon be the of very would really above,

a in Maybe questions bit couple Okay. hear. of Maybe That's funding. on shortfalls the a expand the around the to great Medicare quarter.

think I October. specific component in that missed I

Just maybe impact what there? was saw that you the quantitative

Yes.

So subsidize Medicare -- for we help commercial the assistance provide patients -- patient issue copay to is the copays.

for do patients. Medicare You that can't

the money that disease So generally their were supplementation the copay a fund of disease year. be of on Medicare sent rest doctors chronic October rely copay X, assistance wouldn't and for out future, patients they the foreseeable the assistance. saying Around of the funding funds for chronic to letters

of quarter. the during And impact so had we on that ILUVIEN utilization think an

towards We impact Regeneron's year. Eylea on funding sales back know November, during the end that, came copays about I call, they of during and believe, the they talked during quarter. the funding the That started

teens, user the the up would our and over X% growth to in U.S. the between demand to will that So end able X% have was think in it see we and quarter. be expected be We I going forward. we in believe

available, kind as happened well. The going in the of other J-Code his paid there heavy think utilization free time. is assistance we in market and to faricimab Russell at thing October that postpone leftover an use sort other We that the there drugs copay X of lack be doctors that that got of sampling around for was faricimab that of believe using its when for. comments by was mentioned was was connection could easy with was that that alternative samples And into the the

it. trialing or subsided gotten, That regardless and of the when prevalent as there? sense. I in let's seeing those a copay say, much say, let's got on or makes out into drugs, of, trialing assistance anymore XXXX, quarter first you've there Okay, And not the still December headwind the new the really has where you're guess,

specifically first the it's faricimab than some because other mean out, about it's right, I it's anti-VEGFs. one but -- cycled some things the there -- it's think I quite it of think is of most the the that is for more in part, were cycling of I quarter that durable, --

Got it.

so you pre-pandemic to should think I put started XXXX. mean levels. be together, right XXXX? Is mentioning the growth the off thinking growth everything we about that And how back for to are you mean, we way I call about

and I possible, component that you think right, our hope talked tell Alex. will about. cash I as we think future positive driving critical is, I we and a that of flow that's is it EBITDA,

sort and and of be to we growth we that internally, throughout for surprised So around drive conservatively try hope EBITDA model year. XX% positively the to then number,

that. DAY And got you or question the here least it. what's got with Ocumension couple to around around then think readout NEW about it? here Okay, timing sales at last years then a in China, of potential just the there how And

enrollment to second hope So quarter. with the respect early as the expect complete we of I to the NEW April. DAY study, end in as

to commercially stretches quarter, the we begin early about top in close second line talking can we have in are that the the final presentations, medical expect complete in to there. et cetera, both We getting could late If XXXX, data we enrollment would XXXX. and

you To if then very low margin we a give bit that get we little of a the in -- Ocumension in And those here. a be we honest guidance you, China in significant future amount milestone-based with upfront, come money on Ocumension But be. on to might the remember, what be unit of from most Ocumension would sales. the the have took revenue it's early would a sales too --

projections a little on too bit probably to that. give So early

Okay. the Thank Understood. you. Appreciate update.

Thank you Alex. support, for your

Our Wainwright. from next question comes from Yi Chen H.C. Please go ahead.

a taking Hi. is a a Could treatment? you. whether of opinion, product you using potentially the Thank you question. based practices for comment on today Thank in first-line physicians least their steroid change at as or in there change

I using to in Yi, sure shift right? I'm see question, the not practice, broader the continue the right? continue is a more think there need as if and do but we completely edema. address shift a something I do to -- we that's see to diabetic that And understand a of more there anti-VEGF meeting in physicians their in at of more out can't industry drug, every more role mono in focused the macular about discussion inflammation steroids

basis underlying And that's where have of for of edema, what aspect. the X on because XX% the it months. was, quite broad control. a a anywhere need action they by -- have study under are in that persistent from to of used of disease. of a steroids XX% very And to everybody multiple I've inflammatory anti-VEGF mechanism a type frankly, regardless referenced pathology addressing broad DRCR believes The cytokines anti-VEGF from That's more right? the times the the the seeing the monthly doctors And evidenced get of few patients

So the these OZURDEX it's seeing OZURDEX to I data, doctors earlier, both positive at shift that starting think impact, more are see and ILUVIEN frankly, are in growing. ILUVIEN see and and treating why you're patients steroids both broadly to

with has the And a discussed out of see also of talked with frankly, the it lucky what's all is We or dose more while, a for whether anti-VEGF durable ILUVIEN It's the think steroid. about availability longer-term, compared alternatives, It's desire what we've we've right? therapy, huge we significant durable measure potential Eylea. a therapy faricimab. of for higher clearly had that we're and those most very to ILUVIEN, got by there

would the the In market, DME driver not it. primary demand, for say uveitis? European you Got is user

are I'm hard Yi, hard sorry, -- you you to are understand.

you think I be the that uveitis driver. asked if would DME or Is primary correct?

the driver Yes. in growth uveitis necessarily the I'm in asking primary demand, user right? the indication, DME not is markets, still in European

It's say -- both. I it's I would mean, I -- say would

DME to the I drive in usage continue think as we well. segment greater

restricted. is remember, a more Europe bit little However, DME in label our

more indication So a about there, them durable the we that having eventually uptake in us great therapy It indication doctors. uveitis with more the thing of expansion into The uveitis the these though, time in think, of rapid is, experience markets. usage value the gets DME to gives some in us translates or the driving talk see to NIPU DME. is for more that then second of

that to DME. are more in we utilization So leverage able uveitis generate growth then to and in rapid uptake

it. lastly, expenses throughout you expect And stable the XXXX? remain would Got operating relatively to

do. do. We We

would quite are down We the at level QX we not in expect.

some see course the still should and of stable the in you they stay decreases year. -- You over additional will then QX

Thank it. you. Got

Thank Okay. you, Yi.

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

wonderful results day. we do thank continued our call May. results, in which you have release we to to additional Thank early a We as specifically and the in look for forward through quarter first interest everyone your support probably want go today's participating all, will and on and I sharing Alimera. year,

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

You disconnect. may now