KMDA - Earnings call 3 2023

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Operator

Good day, ladies and gentlemen, and welcome to Kamada Ltd.'s Third Quarter of 2023 Earnings Conference Call. [Operator Instructions]

As a reminder, this conference call is being recorded.

I would now turn the conference over to Mr. Ritchie. Brian sir. ahead, go Please

Brian Ritchie

you. This you LifeSci Thank Ritchie is for participating Brian all with in Advisors. Thank today's call.

from London, Amir Orlev, Kamada Officer; me Chaime Officer. Chief Chief and Financial Joining Executive are

Kamada months September X today, X ended announced for XX, results Earlier the financial and XXXX. its

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

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

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

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

Amir London

participating you, My today's in for interest call. to thanks Kamada our also in investors Thank and Brian. your and analysts for

result conduct continuity, is of in a its in To begin, and operation to products be supply I'd on like global of events to recent not interrupted business continue that to with Israel. company its no indicate the Israel, expected the as effects business

financial that year us now to our well has our momentum full will I throughout operational pivot and With XXXX momentarily. to I positioned achieve the which discuss guidance, strong that, business

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

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

profitability first of XXXX Looking year ahead, of we the expect increased fourth as compared last to to quarter from with momentum to annual the X months through be the the extend year.

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

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

trend we our X our moving and U.S., especially a earlier, this the beyond. first quarter experienced we expect of I in we of anticipate product continuation months and the months first demand in to in been While for X Throughout significant continue anti-rabies during fourth impactful KEDRAB, immunoglobulin, of momentum the the a the increase XXXX, growth the noted multiple drivers XXXX, has forward.

in be U.S. has product by thanks commercial in market XXXX expansion and children. the immunoglobulin for share is studied clinically being driven activity to market obtained as only excellent the by it demonstrated that Kedrion's the for first available a rabies in FDA approval significant and differentiated The label growth KEDRAB the to human

Opportunity in the with accelerate existing us $XX million of us the Israel Funds, financial were received to the approval business flexibility, the the our FIMI large shareholder we prospects shareholder. and equity a allowing previously placement provide opportunities. when existing then business August closed Kamada private development further growth enhanced future leading investment firm announced Our with in strategic and late private This and pursue compelling

will the net from discuss existing in this we of detail entire are a placement also as highlight like private more to outstanding debt-free. I'd Chaime our take result down While profit now and the loan, bank the remaining of we are transaction, that balance to shortly, able

Moving on.

our at achieve practitioners steady medical Our care IgG established other XXXX engagement in physicians and our U.S. team opportunities meetings. promoting to portfolio specialty progress to health continues in through and direct

primarily our activities said by have over in these supported products therapies, been that field-based activity have decade VARIZIG As represents U.S. the promoting important specialty and hyperimmune this previously, CYTOGAM in we a first time globulins

We from CYTOGAM about and the potential facility Behring. are in follows for pleased manufacturer, report year-end. U.S. our CYTOGAM Canada that received transfer future to commercial CSL expected technology approval manufactured Kamada-manufactured are excited the of availability its the CYTOGAM, is CYTOGAM of available before previously sale the This FDA The is process growth in previous Israeli now of at of the

advisory and U.S. recently thought U.S.-based CYTOGAM, eight including in have newly our development field. world-renowned transplantation future program consisting We also possibilities. on opportunities leaders advisory established our clinical focused board, first research the new implemented and solid board The scientific of organ for

U.S. the of key the use CMV high-risk presentation for IDWeek important results poster were proactively held of agents said, combination the Boston. CMV in patients, use investigator-initiated presented case, anti-viral at with of recipients. the beginning product, support consisting this At disease of the CYTOGAM, we study of will transplant physicians to lung a of in prevention medical XXXX in the were recently which be meeting, X-year mismatch an CYTOGAM, starting evaluating lung-transplant retrospective this subject are XXX As real-world with

immune Torres, recipients. Southwestern of and mismatch augmentation at antivirals immunoglobulin, Chief, Care that Center, Texas prophylaxis, Division of lung Clinical CMV CMV improve consisting The high-risk transplant with presenting proactive among Dr. concluded Pulmonary the of CMV KOL, of may Fernando University Medical Critical use multimodality outcomes

on. Moving

ahead, continue we as be further Plasma, plasma progress the to made future Kamada with at pleased catalysts, collection our U.S.-based Looking company.

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

continue our capacity next return We first center plasma successfully collection collection immune year. early expand at our and in to Texas the second opening hyper center Houston,

pivotal therapy the development To enrolled deficient enrollment the up we Inhaled Antitrypsin over Alpha-X continues side, the the date, On for of of to ongoing in our patients. ramp have study. enrollment clinical Alpha-X III treatment trial of XX% InnovAATe for required overall Phase

the recommended study positive the independent which time continuation the received encouraging initiated also from Monitoring modification since study observed for Data date. on without recently have data We feedback in Board, to study sixth the safety was and the Safety DSMB, based

on we II/III our study and and acknowledged the in European European improvement meaningful last lung call, previous recently demonstrated as statistically addition, in Agency, design study. EMA, Medicine has the measured the reconfirmed the FEVX In by reported clinically ongoing function the of Phase overall our

We the continue this FDA study end advancing anticipate regarding of by progress year. with discussions to

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

researchers is management to Dekel directors Itshayek formally Itshayek, evaluate known and We look cell a business I'd on scientific finance Prof. of most executive the in and in who continue human like our and one forward years biology Dekel appointed new as Finally, XX over of Benjamin our these we welcome expertise innovative accomplished high-tech medicine. And the industry renal regenerative individuals to leveraging Board. Mr. positions. highly and independent field advancing Prof. and opportunities. pipeline experience recognized Assaf existing financial has were potential and of recently stem of as highly and senior internationally, the

in detailed the third our now over Chaime the first With turn a and quarter X of that, call I'll for of financial the XXXX. discussion results to months

please Chaime, ahead. go

Chaime Orlev

and Thank you, Amir, day, good everyone.

increase of first quarter $XX.X growth the total happy approximately quarter year-over-year driven revenues X KEDRAB in And to respectively. for of demand XXXX, $XXX.X for increased the were of third sales XX%, was the million, report the an revenues The third primarily were of significant the in XX% U.S. million. increase and months to revenues for and a due We're and Total increased months year-over-year market. to X product by XXXX. Kedrion, profitability for

XXXX was or of gross margin quarter the of representing $XX.X margin for months was million, million compared compared a of XX% for representing X margin gross margins XXXX XX% $XX.X first third Total in a Total million months to profit XX% a X first XXXX. of the to profit $XX.X in the third quarter or XXXX. XX% $XX.X million, the

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

the increase, in and the the approximately year G&A X to X% quarter $XX.X compared XXXX of as well The prior of is XXXX, the totaled including an for of commercial to in our of to increase and advancement trial. million $XX.X XXXX. million of totaled InnovAATe III our $XX.X sales first Phase expenses, R&D, third expenses, million, over Operating as other activity as quarter months expenses Operating the marketing, related third XXXX compared period.

expenses to did liability, the which consideration we are financing the of As acquisition in completed the with long-term revaluation XXXX, account to throughout contingent related to for XXXX. all respect continue we of assumed and

approximately third prior up XXXX. $X.X income diluted in a a was third period. XXXX million XX% or quarter for the third XXXX, to in quarter the the as the per $X.X basis per of million income share on of as Net quarter EBITDA fully compared of $XXX,XXX share or was to for $X.XX of net $X.XX Adjusted compared $X the year million

XXXX, EBITDA the $XX.X of up X million compared X first months For in of the first as months $XX.X million, adjusted XXXX. was to the XX%,

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

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

$XX.X in XX, which September to Our $XX of of XXXX, financing, September million includes position the million of total compared as cash on This December announced million net was closed previously million as XXXX. XX, $XX.X from XXXX. proceeds $XX.X

old milestone the total the XXXX. a $XX.X as bank was to In million our of the These paid million of XX, for are payments. we loan, of quarter, addition, $XX.X September balance during balance close cash actions used and in reflected outstanding

Importantly, as debt-free. Amir noted, we are now

that General Before your of would notice the today proceeding company's questions, be December to take to Meeting held also I on we XX. to note Thursday, the filed Annual like

open now call the will questions. We Operator? for

Operator

Samimy [Operator comes Instructions] Stifel. Our question from of first Annabel

Annabel Samimy

Good quarter.

understand Kedrion. the of So dynamics I to some wanted for just

You're you obviously growth been seeing approved time. some it's very for Could -- us tell significant there. some

So consistent label us the the primarily key there growth you of what depend trends the couple next that's those we it else drivers into can think going do can sales? consistent on you underlying refocus And that that on years? something change? underlying tell the growth Is in driving are? Is

Amir London

growth which XXXX positively label implemented into year, believe we and that market, for are It in expansion the impact affect into received question. KEDRAB then of do XXXX. that and the this of you there of market with last end to We the the thank multiple Annabel, significant share. have XXXX, have the the has we dynamics

a exited gone the we benefits. the was and course, almost excellent the it from late with Kedrion, that very The of in are work by the pandemic, the market that the another fact significant exit significant wide also, every which market, there last take of where pandemic overall prior also our hospital and has to until this in product a market share reaching the partner, its back was has market done coverage to the market product U.S. Of end effect. in and the was promote able And to that product. America, that being able year, to

Annabel Samimy

Okay. you efforts us And update going some that have you pipeline regarding Great. can on on? that anything

Amir London

efforts, question? the Pipeline what's

Annabel Samimy

for early-stage take that you from regard to or studies with pipeline any the programs you the you're to in updates clinical any right Anything that now, forward? the that indication have are AAT enrolling willing selections

Amir London

Yes, yes.

So is, AAT, effort call. course, main it about the of inhaled on Chaime around spoke

and regulators, the to with discussion advancing and discussion are study So we EMA. had a we with the positive the recruitment very

year-end. with have before to expect discussion We a FDA similar the

current to product the kind successful safety side of We recently, meetings we the the data excellent are safety has which of our that validated the accumulating study. had DSMB six and from

do of in have previous three addition, products we calls. In discussed other have we early-stage programs plasma-derived development that

product, We have which preclinical a is plasma is stage. eye a drops, that

immunoglobulin is an hyper device anti-tuberculosis scale And for extracting an development. we We from small product, which which in immunoglobulins immune have call system is and are developing, that have plasma. preclinical immune, we [indiscernible] portable purifying it we automated convalescent a

So make will update. these some development. the three under early-stage are which we are material we programs, progress, Once

of three are for products. in clinical preclinical hope studies and studies, XXXX the start we All to them in

Operator

for questions webcast. hand at from gentlemen, you. the this and Ladies stage, I over Thank Brian to you Ritchie

Brian Ritchie

web. couple have A questions of the in off that come

talked been KEDRAB the the driver. products you products being four Maybe talk Prior if you Seems that, year, if -- you've the a like points that, already the about, driver. has diversity a talked various could. there's lot the four you little about of in to will. at primary business, bit IgG your First, about as of Amir

Amir London

Yes. this use term. may Kamada's healthy, if I very business is

we continue multiple leverage in growth drivers think I business. our effectively to

has mentioned, increase growing KEDRAB with an So in share. as significantly been we market

a see products nice four of We required also 'XX. international the growth FDA-approved late

and the team with investing around was VARIZIG our growing. and is And activities CYTOGAM Israel and in we U.S. which in the have the are market, medical, U.S. We business, the established commercial distribution clinical commercial medical in

of it's products So to territories that that, metrics like nice growth. may, I of is one if contributing each and a them of overall all

XXXX to continue drivers into growth this beyond, forward, the with we own. looking we And and expect growth multiple that

Brian Ritchie

Thanks, Amir.

Another question that's come in.

a maybe be about what that bit development for potentially to looking and Now a from the talk you'll has closed, add? placement standpoint private little business looking

Amir London

Yes.

some thanks development to proactively additional FIMI initiatives. So business with we funds, add investment, looking are the the to

acquire, the looking mainly additional transplantation be market the to are bring We products. specialty in in-license leverage to to plasma the currently we that are U.S. could we where products. have This in, on primarily infrastructure commercial established in to or field, either focused

I are then mentioned, that we are addition I grow assets, through be hoping able help And as business, close looking will about, the are organic will a just opportunities, also us. to to we which brought are the which the talked to different such the to us in so proactively M&A. we in screening we -- transaction, continue to and to growth growing an future, And

Brian Ritchie

you Terrific. the I'll Thank you, closing for Amir. And with that, any pass call back over to remarks.

Amir London

Thank you, Brian.

pleased the the with closing, are in X of during So our solid months first we performance year.

We that of ahead million closing following financing. about the potential the $XX are lie excited opportunities the

their all, long-term patients develop, remain we forward for manufacture support look commercialize. and clinicians and new investors, important to we continuing We value. with to products that you thank And creating to support, lifesaving committed and shareholder

stay all and you. hope Thank and Thank we you you all, healthy safe.

Operator

and your line. you for event. us, joining Thank that today's now you may you, concludes gentlemen, and sir. Ladies Thank disconnect

Kamada (KMDA) 13 Nov 232023 Q3 Earnings call transcript