Kamada (KMDA) 14 Aug 242024 Q2 Earnings call transcript

Greetings, and welcome to Kamada Limited Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]

As a reminder, this conference is being recorded. pleasure your my Mr. now is to host introduce It Troy Adviser. Williams, LifeSci Mr. you, Thank you begin. Williams, may

the described to factors company's cause that this management operations XX-F -- -- actual including, statements call with or forward-looking you conference in conference pleasure during differ call by of XXXX. X-K, only company's the events the and either over XX, results statements. circumstances risks that the the of I after Exchange filings call. Amir? uncertainties live that to . Furthermore, results as review the that my time-sensitive will and accurate is limitation, update Commission August Amir this regarding any contents Wednesday, Kamada events future the of and materially undertakes may those Kamada. encourage the to from this involve is forward-looking which the of it and or turn Without to Forms identify said, specific call broadcast, contains date to conference no CEO. With statements London, contain of obligation reflect date the information to

call this second of results. and financial of which -- in review of and strong reflected growth to year I'll in financial we are for results over drivers the quarter the our Chaime the XXXX half the of a into we for strategy is first and balance the provide delivered a summary review more our of successfully a turn on detailed focused XXXX. Then

we questions. the Following will for your open this, call

one, XXXX, strategy strategy financial XX growth of validating as countries. of products quarter, existing strong portfolio X we that through supporting growth pillars: FDA-approved executing to growth and our in organic X is I'm reported start on. are our marketed let's pleased continued begin. upon main So over report operational second the commercial built to last our Kamada's quarter and

inhaled plasma the $X growth; pivotal and AAT that are support billion an collection which Phase product opening and expect our thirdly, Secondly, expedite lastly, to M&A targeting the of centers is transactions, III our ongoing we market. trial over

half achieved detail. year high-level the During was of these the shortly to half for revenue quarter with I'll the compared first progress period of But provide we Total $XX.X quarter XX% million the $X.X the prior will a growth was to revenues quarter year prior $XX.X months to increase the advancing to of of second second first XX% And EBITDA of adjusted million as first, were as compared EBITDA catalysts revenue. quarter. and the XXXX million, I financials. XX% margin over compared up second as $XX.X a significant XXXX, up for each XX% summary up XX% adjusted million the of XXXX. a Total first to the for X year have period were prior

We increase profitability. are especially pleased with substantial in this

cash $XX year flow. in for and guidance the of are In million in to of activities guidance operational our the addition, strong achieved between months financial cash consistent the and to reported million the of XXXX we Based $XX first X operating results $XXX our year, of half with million. cadence our on our to provided half by convert reported adjusted $XX second first reiterating EBITDA EBITDA million performance XXXX, our we ability the of full that $XXX revenue adjusted year, of which expectation of million demonstrates for to continued

X post key year-over-year the strength benefit from to products. of the as our our demonstrated year of FDA-approved diverse including to the months Of significant first in first compared our and half commercial X products of significance, the being Cytogam XXXX. portfolio continue products growth Cadum X We with

the the completed of product have increasingly important launch business we we million by year, others with sales successful of this to our Israel distribution the end coming several expect next and During in $XX pipeline be our Israel the biosimilar biosimilar to aspect in for launched in to quarter, an product, we annual launch will first that become in big potential our anticipate years. between the We $XX million. biosimilars first

of we financial Importantly, in business have ended our quarter continue strength sheet. the $XX.X balance a to we second approximately million very both to the and maintain We strong cash, the accelerate with as engaged portfolio. to growth XXXX. business commercial These double-digit remain expected development process actively compelling support beyond and we pursue are our M&A continued opportunities. opportunities could and well our growth as in expand a which existing

plasma our the we to Kamada progress for collection in continue U.S. centers, operation As plasma

construction specialty -- expanding in Beaumont, San of site of center expected plasma and center Texas advancing in Antonio, so in collection on focused anti-D are successfully while be the early plasma to Texas and located capacity, in third of next types planning to anti-rabies XXXX. first open our month, end the a which Houston, We open new is are our by the

between As $XX annual center $X each revenues collection million. a to new million contributes reminder,

enrollment Looking pivotal III ongoing therapy. at clinical Phase in growth further our INNOXVATE ahead trial for AAT pillars continues and catalysts, inhaled our

which, of protocol, and As the the for an the we a approved, a IND ADC, study program. allow revised reminder, amendment plan FDA filed statistical if consisted of may with acceleration that analysis

this to FDA of before the year. end anticipate feedback continue We further

I of have of half results candidate. and that, to late-stage second first please investigation partnering to the product promising said the turn in to we With and quarter Chaime, go continue detailed discussion ahead. we financial this XXXX. call potential over related a for As now regulatory the will Chaime here, our have to for also discussion a of part progress previously, clinical achieved the

Amir. you, Thank

be the top at approximately stated $XX.X the the compared a of Amir for As quarter Total the the XX% XXXX. revenues to of call, continues million, second to performance quarter of midpoint our excellent through increase XXXX. were

up $XX.X XX% revenues from the For year the were the million, year, half prior period. of first total

annual was X primarily growth the demand market. year-over-year guidance. of increased sales U.S. driven represented The sales first increased the in by due cytogram and both half products Cadum XX% The of of for midpoint our to the

our in revenues Approximately of generated million increase months prior in were margin expanded months the of trial. for for $X.XX U.S. during margin margin in increase the in XXXX the with X quarter first the support of million, market. as X margin prior XX% XX% year well was $X.X ongoing a our income second $XX.X representing XX% million of which was our our was quarter year period. half and XX% over Total Phase profit to Total XXXX. to per gross Operating XXXX the second period, quarter $XX.X $X.XX of of the recorded a totaled activities the million $XX $XX.X first XX% for Net XXXX XX% The line was first planned of as by XXXX expectations. of expenses of an million in as III the share or the million, commercial of $XX $X.X gross months per sales XXXX. or diluted first INNOXVATE profit the or of income to for net compared X share million, second representing compared was

income the income net was negligible half $X.X of XXXX. versus period million per same the first of For for or share $X.XX XXXX,

the midpoint months Adjusted to was million $X guidance. XXXX as X million EBITDA at quarter EBITDA the compared second million XXXX. adjusted as in annual The $XX.X of million in Adjusted quarter of the first was first in to XX% of $X.X of X compared a year our half in first $X.X the of second the the of EBITDA months revenues represents XXXX. of margin for XX% XXXX

position collectively financial remains existing will opportunities, bottom us the our and pursue continue growth top accelerate and and prepared the flexibility and new business compelling beyond strength of growth to support our which line concludes That rates our and Finally, XXXX. to provides strong development profitability double-digit business remarks.

questions. to call the open now will We

of [Operator Stifel. Instructions] Samimy the with first from question The line comes Annabel

Great quarter.

So few here. I had a

First, as to understand what of competitive How where change enrollment it how does of impact might Is my timing you trial? plan, and second during accept on new of just can curious, timing point? a understand there couple in is, would help kind just But from And kind sizing? that expect first that response of sense terms have? the that trying ADT you was other in the the could the where this dialogue So the that enrollment that's Has us if I'm you the the pushback could help we any end us there more have are inhaled fact, a the any And this in see before any then expect? there? is saying market how maybe become the land? if you at do, of this know they impact of of period? statistical is FDA you year. And do the understand I players you you're just And question.

Thank you Okay. question. your for

as we fiscal So during during to quarter. did described the submit the call, the FDA second the plan revised

before We feedback the We feedback hadn't didn't end the receive yet. -- of we expect year.

map previous now the for to us to in that feedback we get to road and efficacy. to discussion discussion initial needed, waiting XX% have to just study be p-value clear around into continues, are regards the XX% additional if we're potentially the So enrollment. going and changing the a about there's order FDA between Enrollment in

reducing of a other of but year. of is study we to always placebo-controlled challenge the be of rare making study. are progress. expect by The disease additional next into enrollment end a will number recently, We general, months difference studies, potentially the subjects page in a study, those sites being reducing In impact and in and terms reflected a of complete to matter and we in opened type recruitment recruitment few -- being of

-- can movement I high-risk with expect next regards CMV. the Great. Okay. And data if on can follow-up we in the to releases? prophylaxis any And a the on guidelines patients? have When yet

mean Is was the that -- You question? . Cyto CMV.

CMV. -- Yes. Cyto

data So primarily of of systems in patient in is with discussed KOLs on out standard different every kind multiple is or on doing. being we different already on working versus U.S. is are the which process the which is the studies document collection revised few few being months, working sorry. KOLs being care, that every population, of It's and based high-risk years, the initiatives on consensus see to data, something Cytogam pulled focused their either a and order historical are benefit

-- be forum. expect believe we to of discussion So part this is next that of we the that going

the moving to year is the having sales we the say into terms next new last and last In X general, clinical performance, this work I U.S. the the in the people doing medical data, that XXXX the data since ground the talking cytogam been are relaunching on fruitful. physicians continue in that and and we've related this market being of almost in to since optimistic can months, that come. results cytogam we and see to year presenting will years And and product

[indiscernible].

for Thank on the this got for you questions curious And III he's possibly calling program lines the David Amir, revised. I would was about I that of you think the where X Richard. trial you just an be you I on how -- Phase the behalf Bautz answer Hello And for stand. the gave answered. I'm time INNOXVATE or is think you. a things Zach. few first stated

few I is you partner I talk partnerships. finding just a regional focused the about global the that guess a little what program. smaller -- question question, you it, Are commercialization possibly a got next So AAT is Could bit? his or questions. First on

Yes.

could we Europe. partner patients are the are These could agencies for the X territories. U.S. It's that on are -- different It X markets we potential be working of the both territories. So primarily, where the X X focused be and business the main the partners and for regulatory It with course, talking separate X with. potentially, partners.

we're and So . working get in and the EMA agencies regulatory FDA the is our focus, as this And product approved. European. order the to U.S. with

it. Got

Okay.

commercial guys to Next opportunities. . question, development Or stage is going be simply you business focus on to in-licensing assets? open products? Are the earlier stage

commercial near focus commercialization on stage. The is stage or

the the of we growth, the by the would specifically the addition So strong we organic commercial another investment was company. that it by growth M&As, M&As. growth of year to to our targeting company, support like to would was -- support like made the in last

we acquired the 'XX would I into we've think U.S. on additional leverage way commercial done the build we've and Board we that our the with we that transaction products common new the and and and late success products. then establishing to integrated to that back happy success with commercial like team,

which up, to Got cash question. All is it. Final ramp right. positive is flow This fantastic. starting

our keeping paying ownership future? keeping in investor retail thought in dividend and So Any potentially your retail to network mind the in mind? the

question comment. . a a or It's

question. It's a

the repeat So please? can you question,

Yes.

guys ramp -- up. positive starting cash flow your is are starting get You to to

retail I interested were and there so So story guys thought know paying that, your investor ownership . in dividend about with network that about -- retail future is the -- about our you the have a and talked you any it you potentially are that in thought

So we question. focused like dividend are BD we on and the the And buy me we pay asked transaction future. we'd the money utilize previous to you to are generating like Currently, in future, business currently an the the dividend on by be existing growing discussed option. also M&As. or business is approved the This the not board. from to continue could In through M&A something

comes line Advisors. Next Williams from LifeSci the Troy of question from

for current your the there of Just wanted and expectations market on share kind what's your future? KEDRAB of expand

is that believe XX% share. to between market the we anywhere kedrab market, XX% So U.S. in

We product. continue growing the

market We in to that room the product the share. We past. discussing grow have believe been XX% continue still has above the taking we

even the . revenues by have we can this that Cadreon coming X and minimum grow it further. believe guaranteed We a and is million like commitment for $XXX this years,

the are you for of question-and-answer questions? Ladies turn and comments. end have gentlemen, done floor we Mr. session. like now London I Williams, the Amir reached closing would over the to with to

is second closing, results growth quarter in reflected of our So strategy the half XXXX. the the first the financial of in strong and we execution successful in delivered

forward our to main excited clinicians during growth to that advance the our . important develop of commercialize. hope presentation. continuing our joining all today's we safe, patients on look and are pillars to with and We the thank everyone. their Good creating call. support about committed you stay healthy We We the investors We thank support life-saving -- products described value. to you for and strategy opportunities of and day, long-term remain all us and shareholder for X

you. This teleconference. concludes Thank today's

Thank You participation. your for may you disconnect your lines at this time.