Earnings call transcript Q2 2023

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Operator

Greetings. Welcome to Kamada Ltd.

Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. this being note, Please Instructions] conference recorded. is [Operator

the to may Brian this begin. time, LifeSci over turn I'll you At Ritchie, conference Advisors. now Brian,

Brian Ritchie

Thank today's participating you, all and in you thank call. for

Amir XX, London, me Orlev, Financial XXXX. and results Earlier Officer. six Kamada financial Joining Kamada its the Chief Chief announced from today, for Officer; and Executive months Chaime are three ended June

received the website have not this Investors at of you please to news If go company's page the www.kamada.com. release,

Forms would XX-F caution involve X-K, specific filings cause Kamada. contain results operations that in identify with that actual I uncertainties during and like conference may Securities call factors statements. forward-looking will results made I the begin, company's management this to described events from Commission, those review forward-looking the materially we Before company's to including, the of to differ you and future regarding risks or Exchange which comments the encourage by that the statements and without limitation, and

Furthermore, live statements of as circumstances of or obligation any is revise date that events of reflect of XX, the contains accurate the call the to time-sensitive after this Wednesday, Kamada undertakes the only August update XXXX. no conference content or date this to broadcast, information conference call.

it's the With call Amir? over my turn said, pleasure to CEO. that to Amir London,

Amir London

which positioned pleased discuss our today's continued both and we I'm full our XXXX well momentarily. to Thank in second for quarter, your report analysts start you, will guidance, call. in XXXX operationally. to financially interest and Brian, investors thanks achieve And the year participating and Kamada for the are I in also and to to strong

business year-over-year six with of with the growth XX% We bottom a of financial in adjusted achieved of growth of anticipated to and represented half the $XX.X as our high-level total XXXX, I million increase months strong the in EBITDA million, for our which of will line XX% months the begin six $X.X review compared of first and top an year. results revenues first of the (ph), first of XXXX.

our FDA-approved a KEDRAB Importantly, leverage four the further portfolio Israeli effectively XXXX: WINRHO the CYTOGAM, distribution acquired of for our VARIZIG late sales we U.S., in distribution and continue growth increase to hemogloblins significant in drivers, and in HEPAGAMB, multiple Kedrion and business. including

to ahead, as the of enhanced Looking with the expect to we the for profitability half extend year. last remainder year the first to of annual through further momentum be XXXX, meaningfully compared

$XXX of reiterating The represent year XXXX. the revenue over As to $XX our and adjusted such, XX% million to we full EBITDA $XX million XXXX approximately growth of are range million of million. profitability would $XXX guidance of midpoint

anticipate of To significant downside reiterate growth limited previously, what with double-digit revenue we risk. foreseeable profitability continue us, annual said the beyond and XXXX, we years have ahead to potential upside in and

in agreement FIMI, placement. previously leading purchase into in ordinary Kamada, our million As the a under of reported, existing additional allows private $XX shares we an May, private FIMI of will with entered which a shareholders in Israel, securities firm purchase and equity

month company later XX, the private approve of shareholders held to placement the of meeting general will on extraordinary be this An the XXXX. August

company's a average As closing issue prior share, XX during agreement. will approximately shares the of Kamada shares of to the trading XX.X terms a the NASDAQ per of aggregate FIMI purchase to represents the million purchase reminder, days on which under an date of at ordinary of the agreement, price the price the $X.XX

process the the This us XX% beneficially to company's shareholder a transaction, own of and the outstanding of business closing accelerate of and Israeli shares flexibility, it upon Upon be expected FIMI approved, with investment, within meaning provide the closing development will is approximately and us initiated shareholder Kamada's up that private ordering if controlling the expected law. the we is the pursue will receipt have become growth of of existing allowing our the compelling placement. approval to strategic of further opportunities, financial to of business ramped the company

our anti-rabies we to immunoglobulin. our U.S. business, March potentially to distribution existing further exercised were month scope in Kedrion begin active let's KEDRAB with Kedrion the option last in discussion XXXX. respect to announce to of expand its With for our collaboration. KEDRAB, pleased agreement extend that our has with through We Moreover, the remain

$XXX approximately from a to generated be annually. sales of the we KEDRAB market, total revenue XXXX, million estimated further of $XX in During in distribution to Kedrion for is million U.S. which

year, increase XX% second product the the gross half further During months that for product more year this of the the first the margin a significant to for generate and the Also, even a U.S., we in of momentum in includes than we experienced months. as summer this continues reminder, six in demand Kamada. anticipate

our specialty partitioners immunoglobulin healthcare opportunities other our XXXX engagement physicians progress to good established Additionally, achieve U.S. meetings. to team portfolio promoting continues during and at in medical and to direct

As speciality we over been have first CYTOGAM activities field-based activity by market. supported a products VARIZIG, in the therapies, have important represent and that U.S. with decade in primarily our previously, said time promoting these hyper-immune

products, seeking this our related the have understanding positive we that We remain encouraged key conducting to from on feedback to a demand. symposium publish growth in medicine, of U.S. by data physicians received to new while are impact will educational positive believe contributing who clinical continued

Behring. the today we approval FDA and CYTOGAM completing to similar obtained transfer of in of completing in successfully no in thereby this after U.S. Israeli supply this facility product the interruptions, early application quarter ensure recently product. continued of of the Health at we Canada, to CYTOGAM happy announced the a of with of Israeli our expect This sell Canadian initiate Importantly, we report of to I'm the markets CSL from this tech to our fourth the facility approval manufactured year. product its our from that manufacturing technology May transfer manufacturer, manufacture the approval year, prime and

with ahead further looking catalysts. on, future Moving

the pleased to at made U.S. with Plasma, be progress plasma we based company. our collection Kamada continue We

the XXXX of acquisition Beaumont, supported specialty Our plasma the entry fully becoming market center product a Kamada's goal U.S. into collection represented collection strategic and of plasma integrated plasma in our company. Texas

expanding plasma premium are second on opening our center Houston, high center, tend collection XXXX. the we our at Texas capacity collection We in first and successfully early in

in enrolled On is pivotal the Phase Inhaled study the Deficiency. the over enrollment is development the end therapy Alpha-X the for acquired treatment of side, enrollment of patients function from update EMA, to III that and our the ongoing positive confirmed July, Medicine ramping advice acknowledged clinical the by through of previous demonstrated happy study. approximately improvement Agency, ongoing for in has statistically our XX X/X the And I'm XX% our to the received European the trial which today Alpha-X we've InnovAATe meaningful that Phase in of FEVX we the design recently European and measured lung study. Antitrypsin clinically scientific study

As study primary a the current of of pivotal reminder, Phase and X the our served results selection basis of study. a as the previous design for endpoint the the

by to regarding discussion We planning are of progress complete FDA our end with the year. this the study

Alpha-X represents of $X is product the of with in a a Inhaled AAT quality the investigation treatment an over Europe. and transformational life patients to reminder, Inhaled standard opportunity for annual and as the better Alpha-X care. IV non-invasive it market treatment innovative at-home in is current use Kamada's compared the a The leading product is a in sales stage, expected substantial of ease U.S. be in already treatment billion to new that advanced clinical in and As

Chaime, for a to I'll Chaime now over first the go please and quarter second detailed financial call results. turn that, XXXX ahead. With our of discussion half

Chaime Orlev

and revenues an for quarter The of Thank were KEDRAB for $XX.X increased of million, driven the day, the increased increase Amir, half growth XX% you, $XX.X the Total and total everyone. and quarter good revenues first year-over-year million for respectively. were XXXX, months in six the to product second was and U.S. to XX%, market. the of Kedrion by sales demand during primarily due approximately

of manufacturing delayed strike a As of were due sales in the Israel. portion XXXX, the second quarter a facility company's to a labor at reminder,

quarter second the $XX.X margins, $XX.X XXXX $XX.X to the XX% margin million for compared representing of representing XX% the or XX% $X.X XX% quarter were profits six second was to million, of XXXX. gross million in profit gross the million, XXXX. margin, of months Total or margin XXXX in first for of compared Total half

gross the quarter for gross were margins a of $X.X second a strike. result As by profit as loss of the and a affected XXXX reminder, million labor

were As expenses accounting sales the discussed, generated through associated intangible depreciation is The per included IgG of XXXX and COGS such and $XXX,XXX, which product. respectively assets, late our million the $X.X of approximately and acquisition expenses previously marketing company's with depreciation quarter. for company

second year quarter in $XX.X an quarter XXXX, Operating the approximately of over sales other R&D, including expenses the expenses, $XX.X to totaled million the XXXX. and totaled $X.X marketing, the Operating of G&A expenses, half half in increase XX% first XXXX. compared first and second of the of for million, million of

mentioned, expect to This Phase as continue compared XX% activities as as invest our to InnovAATe we XXXX. -- III to XXXX As commercial during trial. we between XX% overall operating our previously expenditure increase well we to is our as

throughout to expenses and for in consideration liability, as $X.XX Net XXXX, compared all income per $X.X long-term share share the the we a did to which completed the the net to $X.X are with second or the to loss quarter basis on of a acquisition account financing for in related continue contingent million reevaluation As of of period. of we assumed approximately XXXX. a XXXX diluted or year of fully prior $X.XX per respect was loss million

quarter million quarter second $X was of in of EBITDA to for Adjusted the XXXX. XXXX compared million the second as $X.X

half months $X.X EBITDA of million to adjusted the $X.X was in compared first XXXX. million For first six the year, as of the

reminder, second labor affected -- the for $X.X of of As were by loss for as the a six a months XXXX adjusted strike. result EBITDA million the

for compared for EBITDA excluding adjusted represents months to EBITDA, the XX% of XXXX. the The labor a of XXXX loss adjusted six increase six strike-related months the first first

XXXX our Amir midpoint fiscal are million. revenue approximately to to As year such year million XXXX. of to range compared XX% growth million as of and of represents earlier, reiterating The $XXX guidance adjusted $XX guidance million $XXX highlighted we $XX full EBITDA

KEDRAB year, of the of market sales In to in the Kedrion product second anticipate in support half continued growth. sales of the we of growth

efforts marketing well by ongoing sales of products. growth in Continued ex-U.S. of expansion the product of fueled the IgG sales as as U.S., the the these new

year expect the first profitability second half to In addition, we compared the of in enhanced the half. as

million the Finally, compared the activities operating in $XX.X XXXX. million quarter provided was as XXXX by provided of by of second in cash cash $X.X activities operating second of quarter to

million. announced recently close $XX proceeds the Our not million total the include this XXXX, from quarter. which later of XX, net expected figure This does $XX.X financing, position to June as was cash is expected

concludes That our remarks. prepared

for call the Bob? open now will questions. We

Operator

you. this line first Thank Instructions] be session. question. Our a Stifel. with [Operator proceed your we question will At question-and-answer Samimy from time, comes conducting with Please Annabel the of

Annabel Samimy

my here. Amir I and couple questions. a Hi, have of for questions taking thanks

still So the arrived to understand Have with you enrollment clearly, this [Technical to endpoint you initiated program, navigate to them to and need to can in the InnovAATe traction the I Difficulty] ask of progressing, guess, -- program wanted FDA understand it's move the sort I I to U.S.? Thanks. areas want us now. I you're guess, in that it's EU [Technical Difficulty] discuss what at points about forward trying which an tell with around? the

Amir London

you sure, I'm maybe? Operator, enough. well can question you if heard repeat Annabel, I the

Operator

your questions repeat Annabel please? you Samimy, could maybe

Annabel Samimy

Can Hello? Sure. hear you me?

Amir London

up. breaking You're

again. try Let's

Annabel Samimy

Okay.

help was I EMA you news the design have you've in chosen. And study? and the around InnovAATe endpoint that still this support endpoint. is just accepted good that of of you chosen, that the the given an terms points what that you sort as the EU. you're that's trying have with the continue in to the about they this, with FDA they us to still So Can they sticking Obviously, they've and understand initiated have program navigate asking of

Amir London

Great. thank We you -- for the question.

the EMA we issue of It's The in the the a was regarding fashion the We with have design and FDA study. the don't study have FDA. or challenges an FDA/IND. between under harmonized any -- designed

and sequence on getting we reporting the the this that the do EMA, meeting with And with ongoing to Just date of the had kind end we generating and of to including FDA discussion a data we the started of to feedback. them. the the plan progress advice and today meeting the data, year, submitting by scientific on we based plan the with

included highly of FEVX and primary reiterated that agencies, in acknowledging encouraged we Both as our meaningful study. EMA demonstrated endpoint received improvement and the today's of the study. the from by And of we very release statistically data EMA previous FEVX -- feedback positive and European FDA, of reconfirmation endpoint are study the were what the the in the overall the is supportive that in clinically design we the

FDA similar expect data later progress we receive the this to So update the feedback and year. upon from the providing

Annabel Samimy

rare Okay. enrollment there [Technical learnings around facilitate in Great. a the your difficult learning anything that that Europe disease Difficulty] you're Is obviously U.S.? in and And This to is enroll. the could from enrollment. experience

Amir London

Yeah.

is So an under IND. the study

of standard standard in is Alpha-X naive done of with countries where not with because do a treated harmonize are study the everything requirements actually, course, submission care will study, So Enrollment the patients, study. care, it's we primarily are currently currently of MAA, is placebo-controlled IV the the upon the both, there which study. same meet and for successful completion BLA that of of --

in the orphan easier FDA-unified It's FDA. study IV to Europe. available is why of a it's for are not want places European that, study, a this that's and U.S. marketing under where generally, number a with reimbursed, for is I patients and reemphasize recruitment in will But acceptable if patients, it's European disease countries. an or currently FDA fully not submitted And for this successful, on limited to agencies is an primarily both IND, be we by So the especially European in not improve authorization. focused again,

Annabel Samimy

And can ask Great. just one Okay. last I question. if

allocated Maybe potentially be the but about you or that business potential you're about So any programs I to preclinical you you're can you're $XX be closing that might talk forward -- development, on guess, going congratulations of that the talk you focused can million soon. on? to priorities moving

Amir London

Yeah.

like kind potential would of related to to I question the answer usage the first, of So product proceeds.

very this. our of And we've XXXX growth, the basis business are done establishment of our be we that's we as approval result believe a in this that focus. U.S. commercial of strategic and a additional with position leveraged as the the full of development FDA So satisfied significant globulin of could that infrastructure for and result

additional specifically products So of expertise, we or opportunities transplant-focused [indiscernible]. are our looking within plasma-derived for proactively areas BD

around and So to course, searching to significant activities, be development. I preclinical Alpha-X our looking One discussions opportunity. BD the to III our main we, being proactive efforts, previous pivotal we to the in In in very added think, is regards around portfolio, in market early-stage U.S. for announced kind market. of study regard a being the Phase assets three drops especially eye with preclinical that in right efforts programs, a the addition have But in that, ongoing. of which plasma to are

for second The globulin around immune TB.

do prepared of that for have the for currently deleveraging not company globally one globulin the to business. as in COVID, develop areas very like during production globulin immune and time is well similar requirements of hyper as gained fast plasma-derived we've unique kind And to that innovative the need, anti-COVID pandemic, be approach third a experience immune we'd especially first the of for potential the underserved being immune globulin, during future sufficient

the main R&D are programs, that's of all So them preclinical our department. progressing Three nicely focus. by

Annabel Samimy

you Thank Okay. much. so

Amir London

Annabel. you, Thank

Operator

you. to At this can turn so back floor Thank take management, questions I'll from the the time, web. additional we

Brian Ritchie

Thank you. web the couple questions of We a here, additional from got Amir.

Inhaled there the your shorten EMA, based AAT? regulatory pathway is in for with discussions on First, an Europe opportunity to the

Amir London

Good question.

acceleration or they do current power while do physical support [indiscernible] not sample potential So the reduction The [indiscernible] size with timelines advice the study and of size. current a the it's such reduction discussion part a size. study requirements. through EMA meets through inquire of plan, sample The of not in EMA. they confirmed acceleration encourage did a the regarding We scientific support sample potential the

and the smaller we So sample enroll. XXX we will plan have that XX% XX study, patients patients this on staying I are size. to feedback accounts That's enrollment. over from a that of come that we the acceleration for with Earlier, and not mentioned this

Brian Ritchie

The the can Amir. you, in you U.S. the Thank that for dynamics driving web, KEDRAB? increased the demand are market question describe final from

Amir London

Yes. Excellent question.

a increase as sales in a supply market. increase we all, for U.S. we the to Kedrion experience in in do demand, call, of first significant the significant So further during mentioned our

and rest moving XXXX. the forward that dynamics expect for and of We that into those this to XXXX, continue year trend

in taking million market dynamics the to what's we and first, leading expansion So When so market. we significant let's share to, are the $XXX this analyze significant say, increase,

market. in They would efforts regards like very globulin doing believe are providers. exposure clinicians the the in very case teams awareness Kedrion marketing the are rabies of I team product-induced emphasize healthcare strong of anti-rabies the to well. we the suspected our of very to that see are we actually effective with in to need happy in increasing collaboration immune marketing reaching and and with We And the southern using animal. that

some And represents differentiation on-label compared secondly, which its advantages, our to has including product. clear product pediatric indication, the a competing clear

effective marketing which the and collaboration the expansion good So with share experiencing strong positive a efforts, that the -- we're to in between Kamada the the differentiated are the market. growth product, U.S. team very leads very Kedrion very growth a we and significant market further experiencing and

Brian Ritchie

the questions Terrific. No further Amir. Thanks, from web.

over closing I'll call So you for turn any remarks. that, back with the to

Amir London

So posted on by the listeners. web and that thank for questions in good closing, the the were you

year. support. selling committed ahead to million that you interests long-term following $XX of support performance with your and patients creating shareholder clinicians develop, products for value. we manufacture with to and remain important to thank and the all life we continuing are We And We that pleased the in forward the about opportunities the our We're We the the approval half potential potential financing. solid first excited of look lie commercialize.

we and of So safe. stay thank healthy you all again, you hope and

Operator

today's conclude will This conference.

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

Kamada (KMDA) 16 Aug 232023 Q2 Earnings call transcript