HUMA - Earnings call transcript Q1 2024

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Operator

Good morning, ladies and gentlemen, and welcome to the Humacyte First Quarter 2024 Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Thomas Johnson

operator. you, Thank

are with from everyone proceed are I like results These would statements that and Before cause experience could certain the or statements remind actual statements law. securities that U.S. differ call to made to risks under uncertainties materially we to federal call, subject historical during forward-looking expectations. this present

filed or made cause with on statements this factors the our concerning date accessible to results obligation from Information information our website. forward-looking we actual periodic after SEC. press update hereof, required release no that be the in this Form as the filing, could reports call this may in except by The presented and made this call from morning the as Additional XX-Q, the is speak and contained statements to issued law. of of Humacyte which, on forward-looking call undertakes differ during revise company only the the statements, on is page Investor contained

XX, me Chief will of financial Humacyte company's Development Laura for will Dr. Chief progress Prichard, the results company's President and recent Chief Dr. XXXX. Officer. Sander, March are Officer; summary the Officer Officer; from on Dale today's Niklason, Executive Corporate Chief the and year weeks, Heather Dr. provide Financial Joining a quarter Niklason review Operating call and Dale during the ended and

remarks, prepared the will available their Following team your be for management questions.

turn will the Niklason. over now call Dr. to I

Laura Niklason

financial results update us and you joining XXXX our morning, for first call. everyone, Good quarter business Tom. thank you, Thank and for

a anticipated been to our License set team market with launch. commercial date granted August this engaged The trauma in XXXX. Humacyte. HAV for XXXX Notably, Humacyte actively Application U.S. FDA HAV activities of support PDUFA has for of our productive has in start entire XX, by been the the in the FDA Priority The February for Review accepted readiness Biologics was The vascular year. indication the highly

a the surgery variety small-caliber across addition, In of in bypass in presentations, scientific and BioVascular our featured cardiac its a using dialysis the promise pipeline, HAV. access, diabetes medical highlighting of in and HAV using Pancreas including broader version be HAV continues type X the to significant

Finally, strategy. with we balance Capital, our $XX our arrangement in in executing sheet under and equity of strengthened $XX million XXXX enabling raise a continue our us funding corporate Oberland on with to February million

results. During call of in these review turning I'll today's up for be happy for before to the open detail a our developments Then more financial review call, questions. to we'll Dale the over your call

our begin with HAV in program vascular trauma. I'll

in XXXX, of that submitted the to our recall December FDA. BLA You'll we

call, positive our discussed our Phase as treatment wartime in FDA. clinical During the was injuries of in from our by as trial well we last II/III detail results which robust under package data aid quarterly program submission, supported evidence the included humanitarian supporting that the real-world VXXX the Ukraine from

preparations, North HAV in process. track for the review action the trauma. and of vascular review our date inspection remain BLA on The with Durham, its approvability pre-licensing part and in the our commercial August remain of a in our of as We and granting Carolina trauma, In BLA confident launch vascular in the we FDA Priority February PDUFA completed Review XXXX. of facilities XX. establishing has accepted FDA goal manufacturing BLA of

budget impact recent Presentations of ensure model completion potential to are that's current in of the accomplishments the designed budget the compared of standard the Review upcoming a to is the company-wide throughout and vascular of results as upon the the U.S. results model, multidisciplinary impact program we've upon by Building FDA, HAV. positive remainder of the the economic anticipated implemented Among of care at readiness launch value XXXX. in clinical a approval which Priority the and planned HAV medical trauma. grant meetings illustrates and the publications the clinical major

payers, the medical also demonstrations and military team Medicaid awareness U.S. in productive and procedures code of achieving is our centers. build meetings at trauma across or Medicare We're implantation having continuing discussions medical the HAV & through of HAV with In to process the Services, we're for ICD-XX at CMS. conducted at for medical with affairs conferences addition, the an and Centers

Morgan as Sales, at that Teleflex the Rankin a Lastly, high-quality planned recently she after where and vascular sales commenced focused Trauma professionals market hired approximately the of Teleflex, President Emergency to and Medicine who President Vice as led to recruiting at launch. the hemorrhage served we've Humacyte of of were joining support pleased most team announce we've Vice on sales Morgan Medical. of team access is years XXX control. a Sales, Humacyte XX

provide suffering Based Review for innovative forward are medicine PDUFA the date. BLA an who looking We our product combined traumatic Priority package, the of of our are to able the with to from RMAT vascular designation we're from cusp regenerative FDA, patients strength the data on and injury. on being the

unmet the of section dialysis Lee, Turning replay Crossroads the dialysis webinar March A can featured be we provided of Hemodialysis in gaps thorough webinar potential ], of solution Care: [ Crossroads a of as for (sic) patient Prabir found access discussed need Dr. Hemodialysis disease arteriovenous now access end-stage Timmy Dr. kidney real-world examples in website. the Roy-Chaudhury Dr. A that the HAV hemodialysis in Curi Investors of Care to Access: hemodialysis. which hosted XXXX, program leader a Humacyte care. patients and in with Michael and entitled on access. key picture Care of access In the of requiring our A opinion a

XXX,XXX those dialysis Kidney to who diabetic, outcomes was presented the in dialysis study patient patients conducted the HAV also subgroups Fresenius its likely obese Fresenius or we the from nearly adult to Research. particularly centers. corporate we received women, study, a revealed who We Strikingly, Care, The are dialysis of of results most Renal define complication further in-center much and higher access rates. subsidiary, from our that that could that benefit the Care have Medical partner, with objective study more who study Frenova In are reviewed hemodialysis. at

$XX,XXX complications can These these infections, failures, of thrombosis of and access year dialysis high-cost, approximately access include patients, dialysis cost in and high-complication $XX,XXX of access The patient infections the failures. for access cost removals, fistula maintaining to groups. per average including

indicate believe patients that by vascular reliable data standard that associated Based are patients $XX,XXX benefit of per the quintile approximately upper from other more female with access addition, infections exceeded In and could on of year. costs access avoiding AV results, we current care. that in complications the these

capture we've those the the The as a dialysis fistula the will excited HAV you reimbursement data study, efficacy receiving the will kind, collect it for potential of To and support study fistula. complications compared initiated economic as to also this the with comprehensive that updates is progresses. compared VXXX very receiving to the and We're study and will not and health it the help This we'll autogenous outcomes economic data. access on resulting complications benefits provide health on to HAV to in quantify in women. that study, end, HAV safety and first but for the of is as provide is in women named about access evaluate should study, important designed additional information only and women

reported to renal from be with remain patients our VXXX Phase end-stage the trial disease on of Results quarter third III in track of XXXX. HAV in the

available. first trial this after reminder, months, The followed participants XXXX. we when patients will the trial usability XX April a HAV they We As completed dialysis of and be in for for designed evaluate in of during to results these XXX to is look sharing enrollment the forward months implantation. the XX of become

as the the earlier-stage diabetes support in studies our front, the Pancreas, potential featured medical continue observed be survived implantation insulin-producing our and for upcoming of In treatment make delivery to and primates, type results months in X survival On nonhuman product preclinical insulin-producing potential in meetings. conducted or ongoing BVP for with from slated the to our researchers studies enable insulin. to after of studies are diabetes. X is in islets BioVascular which the from a that Results BVP, cells candidate several programs X-month a HAV

advancement presented the have of islets at in can preclinical will from planned Diabetes CABG. results we nonhuman into other cells the been held shown also cardiac bypass Preclinical addition, X-month our human that rodent manufacturing Orlando, results primates in diameter X.X June studies advanced and stem HAV have stem be islets have trials in human American Association Meeting small of being Florida. We'll in CABG. surgery, the in diameter conducted small or In support models. in These clinical graft to and millimeter arrest human the cell-derived studies be presenting these HAV Annual from diabetes of

We outcome any an of remodeling not conduit. the Regenerative the remodeling results a that that and observed HAV has Conference be in which that will is at coronary the have Tissue Engineering promising other presented observed of diameter native of June. and matches nonhuman closely the to HAV primates, been in with vessels These Medicine patency

that, turn I'll business now other with for and developments. Dale of to results And financial review a over our it

Dale Sander

Laura. Thank you,

under date and from X will of provided Management. March indication. of We operations cash million public proceeds commercialization Total months FDA equivalents As the XXXX offering primarily of equivalents the the in XX $XX.X first increase XXXX. months proceeds for for Capital stock timelines million in cash of financial of to Humacyte's XXXX approval HAV that an cash compared net with in believe and used from finance from report, $XX March in at The adequate provided first the cash XX, XXXX, was and our currently net vascular in for cash trauma million common funding well million our million. net resulted we $XX.X months cash the Oberland least draw X had of $XX a from arrangement of the anticipated this for be past additional $XXX.X cash to and of net

either There XXXX. quarter quarter the first XXXX first no or revenues of of were for the

to the expenses, rate for our noncash will the quarter include quarter I first $XX.X quarter run XXXX. expenses, XXXX identical fourth of to Total XXXX, that the to which quarter in overall virtually is expenses, through run of the normal I expense million XXXX. year-to-year highlight operating compared but million of incurred wanted comparison of the first the for largely $XX.X were unchanged of fourth first

Regarding in AV comparisons, first for year of our million $XX.X development expanded and personnel for support research and increase to ongoing HAV The the initiatives first XXXX. and development the $XX.X for quarter to the the the XXXX quarter research primarily current use access million of expenses year-over-year expenses clinical including were compared materials increased of from trials, and hemodialysis. for development clinical resulted

General quarter external and for for compared the administrative costs. during expenses million year professional first XXXX primarily to The slight XX, of $X.X first and of resulted fees XXXX. increased were the to increase $X.X XXXX, period prior months quarter March X the ended million from compared the service

was the The expense decrease in the of Healthcare million contingent compared expense net with noncash resulted quarter the liability quarter to compared $XX.X net first first quarter from with for associated Corp. remeasurement for the other Acquisition of August primarily merger net of XXXX the $X.X XXXX. Other Alpha expense from XXXX first of million earnout XXXX XXXX to the of

for of first million XXXX of loss the described decrease previously. The first Net in primarily liability compared earnout quarter the loss to from of resulted million $XX.X quarter net the $XX.X was remeasurement noncash period contingent XXXX. the current for

Laura it turn back to now will for concluding I remarks.

Laura Niklason

very for commitment to continued as time a I'd all for our and Humacyte to programs. moment partners Thank of is thank to you, the team exciting Dale. all as stakeholders. our like again of Humacyte for a our This take well their

of has our progress but team's our meaningful dedication crucial We our variety across progress, this diseases been look stage you are us vascular Not nearing updated approval making us solution in only with all delivering patients we're Our company's first pipeline, broader and anticipated and also we forward regulatory in potential a to today. you bringing and development. to a thank closer instrumental for keeping reaching exciting joining to complications. our with

ready now we're take Operator, to questions.

Operator

Our BTIG. line Instructions] the Zimmerman question comes with Ryan [Operator from of first

Ryan Zimmerman

had you kind Well, Anything can the closer the inspection How boxes PDUFA you clean progress, FDA? just about us talk guys we're those congrats And before that? Any facility all with help Laura, on of getting observations? checking here. correct? PDUFA. to know that to that was

Laura Niklason

inspection. I'm our and to Quality really oversaw So take She to ask Prichard. ask question. COO, to going Heather I'm this Head going our that of her

Heather Prichard

the our very in our Laura whole, FDA of outcome facility very as very outcome. like the confident. of necessarily comment we HAV yes, in successful completed And had it we single It inspection feel of a of we trauma. interaction on approval we do and very based Ryan, the stated, all remain concluded interaction and the that details, have on the feel vascular with or interactions the inspection won't successfully. and other we And successful a any but manufacturing very on we pre-license FDA, confident was

Ryan Zimmerman

Okay. Dale, I we in quarter. appreciate expected, quarter. your this that. least line They little with were than as last were, running And you then costs SG&A at lower a noted,

modest kind prepare And trauma When commercializations. of us for help We've as us cash help the talked guess, what that you're understand force for for of increase Just of vascular think the occurs smallish step-up about understand preparing those do kind in I you in and today we commercialization. needs? indication. past about in doing when a sales terms needing that

Dale Sander

Yes, Ryan. Yes. certainly,

other for the that And like on of we're so for because time. budget time, a team, with some feverishly that primarily longer-time side need, payors CMS of SG&A core is has marketing we the some the vascular place been preparing level have undertaking and to that, why model the the expenses working impact a working even versus that are activities potential launch, Keep expected. commercial we've in items to number that underway we expenses coding prepare preparation such with standard been including of have are in the use commercial been get care trauma in as launch, had the the of savings of and though mind where HAV which is which somewhat demonstrates SG&A for quite we for that

Sales, force, the The In terms onboard. team indicated President with itself, our actual sales we've sales press of the Morgan the brought release, Vice discussed as actual pleased of we ramp-up we're associated in that as vascular very States. in the XXX which be closer trauma market the brought concentrated past, trauma will be in time the to because X of centers level United about That the on relatively approval. small with will only is Rankin,

So in right you expenses those don't see place now.

level out most that sales be the terms likely. In we to that centers absolute than on based sales XXX the haven't trauma sizing less of than that of in force, will point somewhat given representatives, guidance U.S., the other XX force

Ryan Zimmerman

Okay. and on Very all helpful, the progress. congrats

Operator

line Our next question Kluska comes Kristen from the of with Cantor Fitzgerald.

Kristen Kluska

making add away PDUFA. my is all the months on Let with the access. me top congratulation me, also the AV line progress a question here. exciting on for It's into team start results quarter the Maybe now X I'll

a greatest going you your future how of unmet that's agency? going So the us as maybe where all for can but you whole, -- ultimately data maybe can into analyses, also you these how maybe these findings some of at conversations need then us medical play in that with presented KOL event, particular, the talk to at light to present highlighted in you're the subset about look you've of and to

Laura Niklason

questions. Kristen, fare really set dialysis which us really poorly. a this is leverage their that's fare demographics with great to which Fresenius And our what and has is Laura, on well and allowed enormous partnership complications access database, worldwide, and that's of

patients shout-out done Fresenius. equal. members a it give you're this not I to patients who their just that there's at to now to that with burdened processes. particularly female aren't and Kristen, created care disease more diabetics, have male And And them. But could all more than patients, is those clear We right, for patients are dialysis obese quantitative male not want all clear our other have with expensive patients, so our without access evidence are team trouble research

Because fistula benefits be data patients, right. or perhaps even of lens in We're women going through patients compared demographic of large, particularly of to benefits also different you're So some again, to may elderly look lens the through subsets. but these writ to VXX as greater. those diabetics, the relative the at accrue the these or -- that all the

And for so trial, data start agency, but the those our is once to which for this we our then part anticipate trial, with trial, in be VXXX women-only discussions of both obviously, we the VXX will that the get hand. also,

Kristen Kluska

trauma. moving then vascular And on to Okay.

done not relatively going more is product lot in et to force a trying where small be You've here and do clearly initially out. in be going the then and require cetera? But to as are to to with at their participated also that word a to a of they a from surgeons conferences, the this this commercial target work community therapies bring colleagues well? that essential the is you know they'll benefits product. that and about yield of would be of going them this educating And using to mouth think trial have then that the I new essentially gated you sales it's surgeons tell open setting events, open it But

Laura Niklason

So I'll first. second take the question

clinical have vessel Atlanta, enthusiasm lot care surgeons, for our frankly, trial, trauma these of medical surgeons, really vascular of Denver in for center, of while the and highest and example, particularly both our Shock that our at centers, at having of Grady trauma Trauma, at for immediately so the surgeons in for trauma available, Some expressed quite injuries. benefits something vascular surgeons enrolling the center at surgeons the -- enormous can Johns a busiest the in surgeons of Baltimore Hopkins many see at be

a trauma vein, really surgeons part patients, training. I very important fraction while who at surgeons their that take vascular point to of think out these not it's of care of harvesting experienced large do that's obviously are

these is educating they have around in dig said, a the country. correct. that many by center, at surgical medical major patient you're available, surgeon product, have medical targeting infection, areas doing we're And surgeon medical earlier And center And caregivers. That surgeon And geographies. academic because and of essentially marketing have that, within specific appeal We're metropolitan the geographies, that centers that to local adoption. on for these that. the call, think as metropolitan educational so and that in trauma. we're and usefulness road will just that affairs the are geography for major trauma to don't already there their area, already the work spur if We're shows but our leading conduit have team about of resist in mentioned a the will by adopts is, immediately not is in center going then mouth medical fact, we centers, the even I out if of we biological fingertips doing but a their are to in there is conduits in center enormous that think surgeons particular that we within to HAV, will help word also

Operator

of Company. Benchmark Our next Jackson The with line question from Bruce comes the

Bruce Jackson

Most flavor the little do And getting a a questions to of you the of asking? bit types give What of concluding BLA? how of If just the close been us you questions maybe you're answered. think are my they have could interaction FDA. with

Laura Niklason

are that called asking. what's since after information. And the and January. part the are specific ask also part mid-cycle forth very ask able is of ask questions completed. already back filing, accept they with address going for going been there's of process, Well, we've of the the clarifying file, all meeting, those and that's for after we've a been smoothly, And that that normal frankly, have questions. there clarifying. that They to they BLA a you standard There lot is interactions file and been as they've meetings additional any procedure of They on, which been

already So inspection I we've think our as -- and completed that facility. of mentioned, we the

have Review. for So the we things timelines are Priority tracking would along exactly a as expected, given

the date that see will shift. So again, we PDUFA reason no

along have what is exactly to does we as track. Everything on FDA be the -- not what seems but no course, our expected. we would've of progressing that always Of out we're just indication control,

Bruce Jackson

progress. the Okay. That's great. again Congratulations on all

Operator

Our question TD with comes Jennings of Cowen. line Josh from next the

Joshua Jennings

I mean, hoping in August held could from was talk regarding that in was our is have other assuming hoping approvals get BLA XQ walk in revenues expecting just one date modeling little steps we've initial just should I process that taking up or what and device more -- back trying XXXX XXXX? the that mean, FDA take is follow-up heard commercialization about and of terms at to I'm should that, is you about bit a be I just from there, season. approved, the conservative ultimately, a think you some And should maybe effort. with by the longer. we approach think just XQ then this us through PDUFA I we is, companies, And the initial

Laura Niklason

would like question? take that to Dale, you

Dale Sander

you're absolutely. Yes, And Thanks, Josh. right.

are and of biologic. We be not world the But a process terms getting from of the dissimilar med will tech I too it in devices. think through hospitals,

launch But is of typically, to timeline get in packaging launch, magnitude post expect, just terms that the of the you out the required, if little by to bit some things new labeling there. inserts package and of like done of launch changes the and getting, I logistics and a would driven as mean,

a orders you of promotional to program. could value thereafter, And for of that and There's surprised. of packaging a in approval. been major implement certainly analysis there there'll then associated typically, where get most shortly typically, formal which a changes. product. We which a committee packaging hospitals, is of weeks, I the and with time, some would be or company there's positioned be filling the past, the period launches full guess effort, orders I've launch with any is some expect type then is the soft few start launch the So to responding sort to

great a that the which, has on trauma know, routinely trauma day have they that is order of the that that the VAC confident are historically through vascular while process just the area full number -- on other so success rate the a hospitals they influence hospitals in seen get the in a number that the to and or to through hospital. ordering they've the parallel the a basis rate X, gotten averaged an there's about and ability great from X feel high in a is pretty as through deal vascular go getting of feel manner. process within been they pretty process But would and in avoiding of to a either process hospitals week-to-week because going -- expect, and surgeons -- process. The process and ends like on. you advocates within product had Sometimes we've on success there's necessarily then to get of their expeditious surgeons words, of And not feedback real have get patients being particularly who to high hospital HAV trauma for terms months

Joshua Jennings

capacity helpful. us BLA you get tour it's you approval kind steps to and take sits indication up headquarters today, the super with since facility. And of hosted to on capacity That's ramp just reminder manufacturing wanted early gave trauma the in this days -- at team But -- up to needs tap. needed is been the to opened of us where take vascular the what as these I a of little know your while just manufacturing a

Laura Niklason

ask that to our to take COO, question. going I'm Heather,

Heather Prichard

Thanks, Laura.

And year. product, Josh, of lines. that capacity our the system at that that that have is now, stands manufactures you we out as per as manufacturing as So scaling in growth far our LUNA just HAVs LUNA more putting about with case a as know, X,XXX

out to Our for to facility HAV add year ready gross utilities is and for in a LUNAs per yield. already space about additional us that's annual electrical units shelled already and up plumbed gases XX,XXX

and begun vessels for And we're a and space. prepared to prepared, few expansion we're within then prepared we're for produce that enough the planning to able also be the have So first launch in years.

can produce enough HAVs grows, So for as the demand market. we

Operator

next [Operator of Zimmerman Instructions] Our the from with a follow-up Ryan BTIG. is line question

Ryan Zimmerman

to I had I follow-up want one Sorry, just ask.

to how -- ICD-XXs the could about just Humacyte for any for me. or did wondering you potentially forth. or that AV that kind for HAV, be You the to you HAV, terms little a you're put about excuse want if so talk I'm speak in getting -- could trauma process, it code there you of bit think thinking implantation access out of vascular And timing a you of

Laura Niklason

Ryan. Yes,

the because the in to submitted application for ICD-XX we be trauma ICD-XX is in case the this going indication-specific. with CMS code So code

and to CMS that before decision domain, recommendation, on to based add-on through final until So we code CMS also December, we is public public new have in or for a ICD-XX the technology in don't are with date. in the in be forum we that, was the in hand public on and vessel this as apply The had with respect planning submitted its side expect ICD-XX lower approval on the the to that granted that I March. of projected the think, And But upper June. bioengineered go to a application recommendation approval. And execute code time we meeting in own a domain. HAV the on the at note, application doesn't the CMS CMS just the extremities. for implantation a our which is CMS, already after payment

you that apply hitting an NTAP on So date can the year. once typically and for plan this applying date X, year, that we allocation per application and around is October

Operator

at questions this Results Conference all further in Humacyte for no Call. queue. showing I'm This participating. First time you. Quarter the Thank Thank you concludes

disconnect now your may lines. You

Humacyte (HUMA) 10 May 242024 Q1 Earnings call transcript