BLRX - Earnings call transcript Q1 2022

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 Conference Call. All participants are presently in a listen-only mode.

Following management's formal presentation instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn the call over to Tim McCarthy of LifeSci Advisors. ahead. go Please

Tim McCarthy

operator. Thank you,

other on X-K from with annual outcomes of intent or implied in what are not may attention qualifications are call uncertainties the may operating project Mr. expressions to Chief by reports any call All I At and which turning intend, historical limited condition to contained in certain anticipate, The guarantees your believe, differ of Form estimate, materially update turn not in forward-looking forward-looking these statements other are now used directed. over the following are the pleasure quarterly is expressly similar to like to report reports this may expect, Officer to and Phil facts, filed than by statements. other statements. to make other that statements. SEC typically factors and confidence, to BioLineRx conference include subject to would performance forward-looking filed other identify Actual and involve BioLineRx's remarks the the results XX-F, statements. and factors affect and BioLineRx to my is Executive this the words target, these Before such it guidance, risks call, obligation management, indeed financial BioLineRx. are and concerning statements and forward-looking results. disclaims statements. These business, but is and forward-looking over future expressed BioLineRx's time, Serlin, risk These other or forward-looking

Philip Serlin

Chief will section with our overview our results. first Investor copy Then for a our an press our quarter we begin I as you of and was X-K. Earlier Mali issued It a first is our Zeevi, the Officer, a and discussion results on filed of Financial will financial available quarter. Relations which of this Thank good today. you, Tim everyone us morning, thank also a morning, conference release, in call provide of website. joining

to We will then open up the forward call are your questions. looking and

call Officer; our for brief Development with are the Vainstein, as Ella Sorani, start Officer. Chief a I'll Abi Medical Joining Chief Q&A introduction. well our and

As we a increasingly myeloma as for and transplant both if tirelessly been we stem commercial prepare XXXX treatment multiple have and approach paradigm this history, new about and in successful application by the we are drug therapy Motixafortide optimistic enthusiasm, of to of cell centers. a Driven important part launch mobilization a company's the potential most to position working new patients, the milestone of in physicians for robust approved. this

to on Moving the NDA submission.

would from with As the agency our sufficient the mentioned, timelines XXXX on our of submission months, submit commercial regarding submission. few should of we next myeloma patients. single multiple to have mobilization to for agreed very and projected forward in that pre-NDA moving meeting on FDA in from to held that are NDA an Needless remain it pleased we year, to of stated that a a with be target an obtain aggressively would efficiently in last be completion data would consistent the X proposed Phase our autologous submission with a a Motixafortide bone this our NDA agent the a cell mid-year we to agreement marrow approved. support we FDA support Based Recall as in say, point a mid-December what site stem launch and tech previously. likely package the Genesis NDA for be sufficient transplantation were study that

patients endpoints primary than degree stem P of one cell following underwent significance, session. one target trial in a Motixafortide number X and XX% mobilizing cells met mobilization of transplantation brief reminder, stem secondary only less and after a statistical value administration a of of of of high As aphoresis Phase with in all our only the very Genesis X.XXXX. Motixafortide Approximately

In and cells the of per there addition, shortage arm. institutions of regarding units in certainty in the for the required patients collected session, kilogram specifically approximately number of compelling one only level This often an mobilization approximately aphoresis aphoresis million versus stem in at efficient utilization transplantation a machines. aphoresis enables million Motixafortide more X arm average XX the available higher of where session of is plus G-CSF data G-CSF

turn required we with of regard, under Now, options activities that respect U.S. submission commercialization advancing scenario, be pre-launch a the any broad activities, our Motixafortide would this activities. with NDA let whether the in we commercialize In the are parallel range a partner commercialization of to or all to to our In me continue of to evaluate independently. we pre-launch

goal and Motixafortide. uptake of to facilitate prepared Our be is launch on for time, rapid the to

of XX% relative last roughly perform transplant indication. As would the indicated transplant stem broader expenses XXX more a we required out very and States to quarter, concentrated is of the XX oncology United this centers focused a as limited procedures. be in cell Therefore, traditional across approximately footprint commercialization opportunity and all launch

the and Given maintain with what will optionality and to Motixafortide, us we extract will value from continue respect of with to most we to either in launch acid a globally. commercial dynamic, partner U.S. or allow ultimately this commercialization this the the independently, do

little bit now me about a our speak market assessment. Let

the in have stem that is mobilization some includes Motixafortide addressable As cell value well-respected from we annually which the This over and The grow. continuous third stem extensive XX,XXX this are to exceeds XXXX, party mobilization. shown the over commissioned market U.S. through assessment ZS done the cell indicated continuing market in last a understand approximately vendor a we conclusion of estimated addressable years. market There analysis was quarter, that million. we associates. transplantations number XX% and U.S. is are to the million $XXX Globally, last $XXX has of autologous stem approximately growth the we hematopoietic cell at market several believe in

for opportunity mobilization transplants. autologous peripheral of all the alone collection cell cells Historically, subsequent myeloma transplantation. blood stem XX% was stem approximately U.S. to and mobilize G-CSF used primary the agent Within to market, the largest represents multiple the hematopoietic

use of the substantial of aphoresis in autologous patients costs, related to and a days to target cells already unable the of an multiple number transplantation. in are that of requires the aphoresis for Furthermore, addition to units, who for fact reach in remain to the the need number aphoresis adverse is target instances, increases However, for procedures. multiple logistical still causes events healthcare produce generally to increase the number collection, there the and cells it burden busy a aphoresis G-CSF

include multiple combination, treatment the which of three increase. impairment mobilization. induction all compounds autologous generally continues new patients. data induction subsequent within of the to for transplant To-date multiple standard-of-care have With the therapeutic myeloma advancement patients, or of regimens the risk intensity cell become failure treatments treatment higher four have Recent stem can demonstrated that stem use lead regimens induction eligible intensity for cell higher to of drug such mobilization

in hand, response exacerbated average as the and is this number G-CSF yields one patients two recent XXXX, years Motixafortide. of effective of requires predictor Transplant dynamic few over conducted This the of response, This even and in X,XXX in therapy in the induction for this cell In in for comprising a from are more total but in with few target And data, combination in mobilization Research, to approximately annual trend the increased multiple aphoresis cell of the on market new patients by significant patients years to believe In and And Blood past plerixafor better from G-CSF other with of a and recap by in patients patients the malignant its been years standard-of-care U.S. is it frequently XXXX. plus that We multiple product autologous mobilization, has stem use and cell on to unit transplants. increase. stem plus market this the we autologous administrations total analysis which for introduction myeloma on elderly being increased which total is performance of a the cell differentiated and two for volume in mobilization indicates to moment, has X,XXX pharmacoeconomic need had the of highlights the and than in aged regard. dollar XX transplants by plerixafor in cell in increasing the better Centre growth sessions showing patients. potential transplantation number mentioned, for more the agents, in in the over, myeloma Marrow believe mobilization. impacted approximately evident clinical addition, and stem ever increasing older drive least share based and higher data, of above an stem Based last therapies, increase which will a been hand, become the XX% its we stem that last has use XXXX, on potent XXXX diseases negatively mobilization continues the aggressive at transplantation. stem to gain for to coupled treatment of favorable patients XX% especially remission undergoing the treated of of The with rates, cell and had in The on the reach age the a need initial have plerixafor driven autologous order past. International more upfront Motixafortide mobilizer. over

believe we beyond our that the term, expand multiple product longer has to to addition myeloma In indications. other potential

and plerixafor. briefly our one against me the clinical point, Health global G-CSF solutions, of advanced At team studies for against Outcomes pharma this pharmacoeconomic one will of we leading providers Both Global the talk in two these biotech and were industry. mention of let Now, I Research, briefly performed technology IQVIA, comparing second Motixafortide research analytics comparing studies. commissioned, Motixafortide by of the studies about and HEOR Economics the the

and and optimize were mobilization using studies and significant by of collection of the sessions, cells, the benefits utilization they ability identified plus process,. number payers. health in stem was centers and G-CSF the savings cost cell designed Motixafortide driven autologous its associated aphoresis Both to transplantation significant Motixafortide to executed. G-CSF therefore So during Against reduce with decrease statistically in stem the alone, turn driving rigorously by resource patients, a

alone. G-CSF a the Phase savings compelling our studies X for transplantation including believe optimize cost Motixafortide versus commercial clinical following plus aphoresis Genesis plerixafor launch use these of In in and not data our of nearly the pharmaeconomic savings top less substantial We at new lifetime that Motixafortide identified for and G-CSF. if cost versus the transplantation G-CSF pharmacoeconomic strongly versus strategy supports number for compelling $XX,XXX, surpassed alone. showed than estimates showed strong a the the number with trial all estimates approximately become showing G-CSF our XX% previously stem as Motixafortide study product cross Motixafortide with of net of at autologous Given administration a myeloma studies the support cells mobilized collected optimal view Against of XX% these this trial, a as economic from undergoing sessions. combination Motixafortide combination approved. plus cells multiple standard-of-care from for room in session plerixafor only G-CSF G-CSF approximately comparison of cell single the leave to that study on a should the study, lowered of of data even net Lifetime The Genesis cost did seen from the treatment well with patients Motixafortide aphoresis in by an cost against the case Together centers. for benefits and savings and cost G-CSF, that patients higher mentioned including pricing not in all $XX,XXX IQVIA the alone. can Motixafortide results provide the of of of G-CSF number

briefly about me cancer study. pancreatic let our Now, talk

enrolled. metastatic initially with following and had results based previously final Merck’s KEYTRUDA combination chemotherapy Motixafortide XXX study Turning A PDAC gemcitabine we now PDAC diagnosed with COMBAT/KEYNOTE unresectable progressed stage Xa recall total of patients four of therapy XX cancer, pancreatic second to from the that Motixafortide as PD-X first-line in who anti a program, line triple Phase were therapy. combination or announced positive

data a our progression endpoints as next With in demonstrated steps as compared the the to engage reminder, from biopharma to overall survival, survival, Phase response a all we PDAC As median this substantial X/X with confirmed and improvement response we of randomized rate. disease historical to study rate, data, across including previously potential fee goal study overall rate overall with continue partners, discussions on control collaborating controlled program, for regard indicated, study. median

AGI, to Turning now. AGI-XXX

mechanism are we X/Xa recall to announced and is September dose second designed proof assess Part data. anticancer of to our multiple XXXX, candidate, in tolerability Regarding of quickly array and intra-tumoral that and In The Phase And X, that we clinical vaccine evaluate pharmacodynamic in a evaluating solid the safety, same types AGI-XXX parameters. study initiate safety study. phase. wide we later moved both clinical month, biomarkers a the expansion tumor positive

experience in their intra-tumoral completed our of this in of enrollment in SAB. a highly to announce the and company study like board the with of have of turn Scientific advance and statement now advisory second other CFO prior with leaders and fourth II overview perspectives. Advisory Part of readout Mali announced are I immuno-oncology the we Zeevi We help or key the the of benefiting To an activities go quarter and unique specifically over regard Phase in now would items. financial call consistent we to ahead. this from will fields to please year immune-oncology our clinical brief immune-oncology, comprised and guidance. half formation Mali, the injections field who give X/Xa development thought we AGI-XXX, Board to This is regarded December, our and in already plan

Mali Zeevi

you, Thank Phil.

Research on additional discussion, study, expenses period lower contain $X.X of trials. expenses million, increase As financials, and financial Genesis you $X.X few million, development Therefore, ended primarily quarter this made resulted comparable XXXX. million a to financial compared review will practice, items go and clinical from and in expenses the an were associated review which expenses associated for $X.X for or over AGI-XXX to the X.X%, our our invite we the XX, with The release morning, we cash. offset call, and Development me XXXX let only combat operating in research significant filings the and increase press information. is in March an increase for and completed by the our with this Motixafortide,

financed million of equivalents milestone first the turn and XXXX. into term believe cash, well short XXXX. to I'll $XX.X achieve potentially XX, bank multiple back to company We of And the over milestones creating Turning of deposits with as half that, held cash, to value call are cash the March we Phil.

Philip Serlin

closing, In few to key as custom, our a Thank I'd you, Mali. is upcoming our to moments like summaries take milestones.

for in transplantation multiple Motixafortide patients First as a submission mobilization of stem the to undergoing novel an autologous FDA NDA myeloma cell agent mid-XXXX.

for in Operator launch FDA hope cell mobilization the of that, the we stem presentation. for in part And solid for of Second, U.S. AGI-XXX X/Xa study XXXX. initiate milestones. the second announcement of And term formal in our to call hope a to We up of longer we part the in of initial Motixafortide Phase now results approval With Motixafortide now now have XXXX. AGI-XXX X in from tumors the we open questions. half potentially will to two plan We trial Phase in XXXX. potential for concluded some slightly XXXX. in

Operator

first Oppenheimer. go Instructions] of is question [Operator Please ahead. Breidenbach The from Mark

Mark Breidenbach

Phil, you some quarter guess if for on I'm pharmacoeconomic wondering Thanks market [indiscernible] taking questions, from comments the potential studies offer an congrats the timeline for I European can any Motixafortide for progress. you've and just commissioned on and Motixafortide assessment maybe the for

Philip Serlin

so first Mark, good Yes, to. all, speak of to it's

submission we when So not do we regard market and plan information definitely to on submission, later we know, have assessment to -- done Europe to the is be is something EU, that hopefully year, of And will But be the yet we've is complete should and so. regard disclosing once FDA we year. some as to know, general, we that part do do so to plan our a use you to course, submission. that approach our submission happening, And that that that. of yes, that study, sometime, to next and completed you With in FDA that pharmacoeconomic do. early giving the with this so,

Mark Breidenbach

Columbia It cancer like in University still Okay, looks clinical got trials.gov. at running. just it. the of Motixafortide study looking is And pancreatic

data be on just clarity know, Any if - wondering in if to or next would can year? that expect XXXX, I'm maybe You from see we they're helpful. that any

Philip Serlin

Yes.

So, as potentially in out looking our our in we this coming we're year. half public of filings, disclosed some data at in second now the

However, since study, know, done, say the have not want I or more study, investigator it's it's do to that the we and being controlling we're an control over initiated you less timing.

it's So it's our the in an study. this current year. estimates sometime half are fact the initiated second that of again, by caveated But investigator

Operator

Vandermosten of go is next from John Please ahead. question Zacks. The

John Vandermosten

to commercialization I'm go and assuming the Good SCM? the providers, Mali, would for wondering Motixafortide how know, to you and made afternoon, far Phil, and approval Wondering first you how you pitch process doing? step out also fill payers so

Philip Serlin

would the question? of know So, the like now? what didn't I to question, first to pre-launch activities know -- we're the want first the you right are part of what activity that that you of sort part hear the doing Is

John Vandermosten

Yes.

Philip Serlin

Okay.

So, also for launching we're independently, would believe think we're lot the highest at, would mean, partners, of product. the maintaining one, we're you there lot that But that we've amount that, a bring of we I optionality, you a doing are I the know, mentioned the with commercialization will things I know, mean, and depend be first co-commercialization, looking value so partners. potential value on we're speaking --

One value And course, on of of second the launch so really is doing time. whatever launching asset. takes we have the on to principle, the here. main And two is principles it to time maximize

have would any critical be approach us under philosophy for that overall with of initiated so we to required And circumstance. do in mind, and activities that a number

sure to Medical those messages at initiated in the Affairs of initiate, the investigator XPl strategy, we're you with serialization, are completed those sort party logistics, study example, activities, third supply program. We to areas a FDA. access because chain also et our for an selection, activities to looking like in our all it commercial for brand submitted place initiated things also network So scientific we've And submissions, name drive interest and efforts and we've branding distribution, want also we of like market initiated already for, they're make we're know, selection, partnerships, packaging, to key starting that in a we've cetera.

So are studies. we [indiscernible]

the still if know, know, forward to kinds under done with so can, we'll So, that partner we then these along we're be need we whether you of And if we on the any of that go circumstance, to be then and moving be decide time? independently, are if that able activities done. you way, these make launch to that not, course, happens must sure forth and activities

first the that's the question. part of of me question. second remind your the pitch? part of The Can you So

John Vandermosten

sense was a hybrid about in the places but make Might ask what That payers all? I that that, to split model? just actually, sense you'd to does it not Or targeted that pitch U.S. make just XX only with before -- it a it's up and providers, make at

Philip Serlin

that be, the know, a know, I you of really institutions to XX% a, think any in speaking that think, top custom-made this partners, I represent Stem XX institutions, idea that's, I mean -- represented Cell market you Transplantations top was event, because is when all this even U.S. focus is would sort the the of, in on they obviously, with the we're XX over the

just And those of by own also makes on, those a trial. were potential sense analyses, partners, discussions part to institutions, of those phase we I also know, the think institutions. way know, our but it of our on our really So with three you you institutions number have focus that, based

have, XXX you then, already XXX aware larger our across physicians additional of on And clinical efficacy the they're an the of make that amongst would make our, basis, sense institutions out and the benefit there. opportunistic it full of hospital some the know, to the the itself, spread U.S. of then The of to course, institutions So we drug. the up hospitals

answer So your does that question?

John Vandermosten

does. it Yes,

Philip Serlin

Okay.

of Now, -- course

John Vandermosten

pitch like make, you you'd pitch, the short guess, I the know. that Just elevator on

Philip Serlin

certainty the right nightmare that on the Yes, depending well, the the the amount pitch are XX% of undergo have there target more can and cases, we scheduling many because the a a session, are, one patients give aphoresis we mobilize can say to units building, elevator much bit be number of the the at these to regarding now, you to short have know, issues sessions of but in institutions. that and would cells, how aphoresis I stories logistic aphoresis

hear will whole has they we fact, can a can the process know, that they that sometimes a have, or delayed because In use. to you guarantee seat they that or cannot machine patient transportations that be new -- a

of of having I very lower safety important. aphoresis are the think sessions, also a course, benefits

of I administration, think apheresis of session, the fact get apheresis is occupancy along our and you receptor only require with advantage. which sessions we on receptor even that if one a which the G-CSF two of than at because is top huge we molecule, more occupancy can one

I think that's the pitch. main elevator

we're obviously, studies in we our know, believe -- cost more You show also effective. we're that

So the benefit the the patients, the cetera. to and to clinical payers et the entire cost logistics, system benefit

So our main I pitch. think that's

Operator

at questions There this further time. no are

Before closing go Phil like I two with that replay call the to make would XXX-XXXX. I your you participants concluding call In Serlin XXX-XXXX. in ask XXX-XXXXX. Serlin, to begin a his U.S., Mr. please like ahead conference. this scheduled Israel, call the (XX) (XXX) would hours of Mr. to statement? Internationally, call is X In remind statement, please please (XXX) to after

Philip Serlin

would. cell I summarize Operator. to our Thank mid-year. and submit from Yes, NDA mobilization you, on we track remain stem To Motixafortide

pre-launch under be key scenario. would activities that While we advanced parallel commercialization in any required

indications significant expand launch We moving the of with development and ultimate of on quickly robust of commercialization can Motixafortide are approved, forward of of the with U.S. U.S. of the believe the important excess standard-of-care At AGI-XXX. a indication. we maximizes become can share both in top the We value PDAC, G-CSF working the with that market be in this estimated to use perspective, $XXX to the goal From capture the of respect are the other are million. the pharmacoeconomic if same asset. in believe a time, including the maintaining clinical full optionality in to we Motixafortide executing Motixafortide of and we

a stated next much have the we to for our your BioLineRx, you Thank catalyst update in providing quarter, safe inform the BioLineRx of set interest have look year comprehensive in will for a August. continued rich that great last As all stage the very we evolution Be forward and believe and we we portfolio. day.

Operator

you. XXXX BioLineRx concludes Thank disconnect. participation first go for ahead This you quarter Thank conference the you call. and your may

BioLineRx (BLRX) 11 May 222022 Q1 Earnings call transcript