BioStem (BSEM) 12 Nov 242024 Q3 Earnings call transcript

Thank you for standing by. My name is Rebecca, and I will be your conference operator today. At this time, I would like to welcome everyone to the BioStem Technologies Third Quarter Results Webcast Call. [Operator Instructions] Thank you. I would now like to turn the call over to Adam Holdsworth, Managing Director of Investor Relations. ahead. go Please

Matuszewski, and Financial to everyone, and for our Fortunato, be joining highlights. Executive and Good and Officer; BioStem's thank third call Mike Jason will today discuss the company's results company's quarter conference Founder Leading Chief Chief afternoon, the call you the Officer. XXXX corporate financial

involve uncertainties we I'd over-the-counter like current remarks could forward-looking contain may on results begin, materially to the our to and described with Before from These statements of the expectations inherent cause actual which those the management, today filings company's that risks remind everyone risks in based differ market. that are indicated.

undue You may made forward-looking on and any speak at the are to statements, time. any date cautioned change place reliance only not which as of

financial section to that, now are Reconciliations company's to over as pleased release the or turn measures are While so available non-GAAP to commitment the principles call also to Investor we undertakes GAAP measures accepted measures. generally most website. With refer generally time includes financial typical in of these measures the on laws. This the or statements call in do press company the accounting of GAAP. to securities to that update We references revise not financial the may calculated time, accordance BioStem's no these Relations with non-GAAP unless comparable to I'm by required Jason from certain Matuszewski.

million revenue robust improved $XX.X of the In thank and XXXX, high that $XX.X million, consecutive milestone, million, establishing and third our QX $X.X and Adam, cash for our marking us position new report another growth. revenue BioStem of to performance. you, Thank achieved to all of record-setting demonstrating quarter I'm we has for joining company today. a financial you Technologies adjusted EBITDA pleased posted our of

this highlighting resilience our the market. generated in continued year, For months $XXX in the we've million and momentum first of X net revenue,

BioRetain innovative to segments. strong testament performance especially a is quarter This technology. powered of this the Our patented non-acute success portfolio across range skin substitutes, allograft, driving strength technology of AmnioWrapX our our our is wide of a commercial by

Our reflecting take the efficiency moment our excellence processes. XX%, BioStem our the I operational this the and of solid to entire dedication manufacturing to gross margin commitment want team. of remained at to recognize

Your commitment to drives honor bring what of are these our you outstanding vision results. the and to the donation gift

engaging reimbursement that of leaders ensure access part advocate to within life-changing our certain As recognize and efforts and partners actively reimbursement for high-quality, policies. have to with We congressional caused Medicare access. players Medicare patient effective products, and we've impacting patient to overutilization industry CMS, been policy fair system the

BioStem to not ensures help also our support conversation, at treatments. of only have that solutions. reimbursement this ethical access practices, remains beneficiaries to goal shape Our responsible vital millions and forefront patient-centered supports the but with collaborating landscape to government Medicare leaders of is that industry policy

in Turning extend Venture like to Their partner, commercialization to our growth role gratitude partnerships. journey. my instrumental has been I'd to our Medical.

will on approval QX for the quarter, once studies trials X our a for Medical work readout milestones support enrolled randomized VENDAJE essential approvals by and that QX XXXX, recently journey national nationwide quarter, to early in by results launch early received side expanded coverage our these QX Early to AmnioWrapX clinical from approach, innovative support strengthen and our are preparing our our commitment AC, These broaden major foot them Venture mid-XXXX providing access clinical clinical and all controlled evaluating anticipate AC's final X with allografts. XXXX. had XXXX patients led ASP reimbursement in these results ulcers. launch us the they products. nonhealing clinical an our to for are with this again VENDAJE in clinical thrilled and studies base key across data We side first As our partner, in rigorous regions. of diabetic recently now we're is impactful which published allowing MAC we BioRetain payer of XXXX, of marketing in with in of and and research. We commercialization IRB

Journal an for of Additionally, published communicated achievement of support uplisting our to research-backed the underscoring further as strategy, finalized. We NASDAQ time. our same we're the an market data of for retrospective venous This commitment a filed BioStem's comparing a capital diabetic to standing reinforces and ulcers care the our peer-review submitted final positive data foot in providing advancing findings once our our reported these October, XX in September recently with to validation from valuable products. In In lines designing equity a innovation. were results for on we BioRetain the allografts leg of standard stages study application protocol International Moon study Form on our to clinical with ulcers, time be SEC XX in technology's effectiveness. at leader

currently XX. Uplifting to a are exchange response broader to a investor and and QX, comments to our formal We in review national to enhance a BioStem's along visibility becoming provide fully the wider and working base. commitment SEC SEC with expect with submit the strategic reporting initial through accessibility is amended Form

for our grow. remainder challenges, XXXX industry the Despite is well As and and adapt foundation, strong portfolio and and positions positioned robust partnerships BioStem our effective growth innovation. evidenced us we continued to look of beyond, to by

and confident solid that products strategic dedicated a success. groundbreaking are for team We foundation provide future initiatives, our

of drive our the validation which the our potential Looking ahead, to offerings, our broadening adoption products our diversify presence further to our transformative of team positioning Venture solutions for members ongoing as and review superiority results our financial and initiatives outcomes upcoming I'll broader and continuum over about trust, market we are and and provide improve and Medical us trajectory clinical we results for and payer a you for Mike providers. With optimistic access, BioStem's innovative that, could our our provide QX Thank potential the call XXXX. our trial to of to to our coverage dedication on with clinical market care patient and solutions. for Expand their a strong shareholders. the expand value Fortunato, product bring to have allografts. These deliver of hand work patients shareholders, will who now across support detailed

share transformative everyone. company. XXXX When we're significant results. Thank and compare for you been we've being pleased made the has the growth year, progress the you, to quarter highlight the significant, am afternoon to Jason, for XXXX we year last BioStem's this same is which QX financial results, period BioStem. and good a excited here We to us strong appreciate I and milestones continued today. to with share

the range For period been a primarily the $XX a in is million, reflecting which well by This growth exceptionally record XXXX, strong an XXXX. net third of has performing quarter across of applications. compared continued demand AmnioWrapX, revenue to increase of million driven reached for patient same $XX.X

for in the expenses and in Our associated growth increased and continue with or This of increase service for million prior an for our our we million. was were AmnioWrapX $X.X XXXX $X.X XX% the net year higher highlights $XX.X $XX.X same largely compensation AmnioWrapX or compared and sales of million distributor same period of gross This profit an QX period. manufacturing to bona revenue to efficiencies. Operating was by revenue driven $XX.X XX% operational of net our agreements from increase robust up fees to due represents million, share-based expansion, QX of $XX million last as year, get workforce million, fide operations. increase

in $XXX revenue XX, ended period driven AmnioWrapX, we September X-month compared of experience The XXXX. this million $XXX by approximately net same of to XXXX, the period growth million, which the reported demand. continues majority market increase of For an strong was to

from our This X workforce operations, of bona $XXX an by last increases $XXX.X fees or of first million months same net or revenue service in revenue volumes higher and $XXX operational including distribution the gross driven of AmnioWrapX continued $XXX.X was period million share-based reflects sales and of million, manufacturing investments higher last for growth period was to year. increase the first for XXXX of efficiencies. the Our XX% AmnioWrapX Operating compared $X.X the scaling XX% in related months profit increase improved million million This same were increase expenses and net for fide year. X compensation. to of

pleased EBITDA scale demonstrate growth for adjusted are income positive have net and profitable. that $X.X These the we remaining while to and strong our achieved GAAP to revenue report the meet results $X.X income We quarter million to respectively. to for continue business the quarter was Net consecutive third million, ability

In addition, $XX.X $X.X to million from increased cash of the an our from the million quarter, million. previous $X.X increase in quarter current balance has

XXXX, XX, million for on there operating the losses heading tax balance study timing the expense XXX income underway. of offset net million sheet, if payable completion quarter Section currently study management of year-to-date taxes the Code has are on any and third This September $X.X Revenue the $X.X determine Regarding the Internal estimated income. generated using limitations taxable previously will of year current to

that XX, amounts by the all, these of offset Although if tax expects will recorded most, payable, management December estimate income be by are not this as XXXX. NOLs

results, As we the of look to for continued successful are paired confident our initiatives, XXXX, execution these strong strategic success. with that BioStem we position the financial remainder of

remarks. profitability continue enhance the will over value turn closing call and for to for growth, now We shareholders. I'll to maximize our drive Jason

Mike. you, Thank

strategy our of updates will strengthened and for our with space ensures finalize our some strategy [ specifically XXXX. driven pricing model. This of of resilience for and for and business. $XX.X As for reaching of underscore substitutes CMS to our revenue Medicare EBITDA nonacute the cash for adjusted ] milestones demonstrated substitutes, $XX.X million current we Services, physician team. year and $X.X in coverage a and plus CMS, or in effectiveness high continue scale to an coming pricing centers million of position methodology with BioStem's skin bolsters decision and our confirmed the we QX I'd like a have continue payment office financial the just outlined this the stability results that significant Friday, policies quarter commercial pricing a pricing confidence can they address the X products. Last BioStem skin and exceptional maintain segment performance, marked ASPs Medicaid several on its that growth million, new their as and as for our

to leaders the MAC industry with proposal on including beneficiaries Now regarding rely actively could treatments. undescential This Congress, policy. the the who access LCD. coverage impact for proposed limiting ours address potentially engaging these We're Medicare and products, CMS,

and Our is well-founded a coverage patient safety. advocate to ethical policy goal that balances for equitable with practice

patient market, we some to collaborating access effort, to this believe closely BioStem overutilization more expand that While approach in remains industry stakeholders is at parties access government forefront doesn't products. place with needed, a of policies acknowledge one life-changing risk. we patient the the by rigorous that at support responsibly and

evidence efforts, Our comparing of trial BioStem's plans, products. Capitol and This which of subsidies, on and beneficiaries engaging involving the ulcers, diabetic essential are foot clinical equitable XX is the Alongside ulcers, BioStem. October an of include base the and trials focused XX Medicare payer patients our better, to leaders, for Hill more demonstrating anger on both commercial these superiority with value care. or study coverage leg kickoff across skin BioStem's closely across Medicaid. sites standard the key Medicare study benefiting Advantage to clinical treatment marked to expanding building pivotal coverage upcoming

and in our over from on membrane of BioRetain the ulcer underscoring supports and challenging for channels. significant published in the In in results across of treatment-resistant foot address strategy strengthens superiority the and to International This results traction the wound a to care Medicare, announced our ]. These potential other coverage Medicare highlight groundbreaking clinical [ commercial BioStem's clinical October diabetic involving expand we standard often DSP Advantage retrospective process BioRetain publication Medicaid and market, study payer closure, placental LoomJournal the credibility addition, gaps wounds. payer

which solutions could will that We about position get as We amendments proposed not in strategic the without BioStem. study implemented it the concurrent value reinforces chronic remain this favor in as LCD providing being brings are effective optimistic a leader for BioStem's excited XXXX evidence-based implemented, care. wound

confident front, Form we're simultaneously our submitting on validation payer provide with capital a for these markets tech Looking uplisting products, advancement our allografts. and broader efficacy, to SEC commercial the clinical in of Committing BioStem's by expanded that and significant the filing our coverage adoption trials made XX the XXth application. we forward, additional September will driving equity

in our to national plan amended credibility, the are SEC with continue through investor to horizon. growth response and BioStem's initial submit in the enter remain working execute capital, Form and on BioStem's We transition QX. now a our we fully we enhancing initiatives. In formal along closing, and milestones quarter, XX comments at growth aimed our exchange uplifting status and on key This fourth strategy broadening we review milestones reporting long-term to reach value to significant a increasing drivers essential are as an our of shareholder about to access continued optimistic the a as

With this established MAC and the product. of reimbursement recent from nationwide across AC see well launch positioned regions, VENDAJE we're contributions strong revenue to all

This we're excited record growth, have of and about product potential expand our quarter initiatives marks our to consecutive diversify that third underway and the the offerings.

call a to our greater we presence the to strong success. Thank on for with confident appreciate solutions. our and We outcomes As progress that continued and on as and now towards our continue we support trajectory improve questions. we're expand we'll to look patient value shareholders, to our up forward open innovative advance work priorities, you, your to deliver BioStem keeping date strategic you is market

first an Your [ from Instructions] ] individual the Bennett line question of investor. [Operator Kevin comes

on good A the there. job quarter

I'm that? more diabetic burn questions. my a Maybe have exclusive And an possible that had deal profit we brush Is like like of maybe wounds. with on all question a cost, cream then know work -- like having that, give and restricted. a give million million what and happen like them this assuming $XX could like something. guess, third I Just the restructure share put or then you would a share actually structure, the an that know them maybe question uplisting, is my structure? business? on their us don't we're and out it that on few of security thing liking have, with biggest to like if is will about Second I I this like is product I distribution actually us for spray they the victims, $XX air the the million $X thing

the I questions say can curious If all that's Just have. what will with happen that? I

for being appreciate I Kevin, and a really long-term questions. shareholder, Thanks, the

we're our First with of regions. amazing now, continuing team, to distribution all side job access of and MAC on foremost, expanding product the Right the they've Medical. across done kind through that an Venture and work to

of type perspective, W-X now, we were from with relationship kind right at to, think I we're similar sales And looking guess, this getting if marketplace force product the near we the see to type to in internalize associated continuing competitors, in compare of it term. would this of I out think that costs a into maybe I marketplace.

what regards On a are the to call they cream, second considered actually, question in allografts. products tissue our

we a So tissue of of off harvest actually placenta. piece the

ulcers would And the move or and so the then then into be from OTC structure. these acts now, to That of options leg format that's structure stock. would to shares -- million diabetic as And barrier for ulcers, there's ulcers. move wounds, capital chronic bed common capital a a to type sheet are and also wound regards and laid of wound any like foot in it's equity venous warrants Nasdaq. it up across kind pressure and like NASDAQ. third, the cover believe the outstanding that the up me, excuse Right so about outstanding XX I ultimately And

currently, of So plan that's the kind direct with the listing.

with Your from comes of next Instructions] [ the Page ] question Capital. Taggart APT [Operator line

record Congrats on quarter. another

question. quick a Just

helpful with channel Venture Medical. color specifically, If would distribution you me. the around some provide for more guess sales cycle could be I

Yes. Thanks, [ Page ].

of bit Medical. get fulfill how color little kind pipeline kind and just we manage with the So more of to a Venture

with get providers customers what's ] these And process, or ordering wounds secondly, FFO very It's with they us have on conversations downstream on these looking this IVR where a production sizes see utilize run kind typically, to and -- ultimately monitor weekly we're Venture are about platform increase the requests, their size wound lean kind from of quickly continuing perspective, shipping And daily okay, And that their an with is wound pipeline these manufacturing you gets an what see the how can where a they is [ can out and and closer continuing from of, of types type size of a are going we arrangement you product called kind ultimately then Medical and that they're to demand going. In the with to daily verification like. wins what in to that's and called associated a an is is. wound OneView where as Venture us, and idea of from So organization? basis. robust closure. to it then the specific need initial of basis of kind

on have and product to little production. So us that allows insight of a needs kind more bit product

next Watts Associates. [ line Ernest question of comes Your Watts from the ] with

appreciate that showing I you're the progress today. the you made that and comments

buildup you You significant on significant mentioned the were roughly that fairly much costs X give were in second the comment the than in more quarters, please? of and Could each release quarter. what they a

what you little clarify you a say When bit. build-up do costs, mean? question could you your Ernest,

out the to that. costs It your come do are hired in. have money get into people and you to before the to product actual have people Those field revenues

referring revenues. cost precede that I'm So to

Got it.

the SG&. mentioned as to yes, statement, the Venture biggest And Those line are fide of field specific a obviously being services. direct I the correlation Medical specifically. there's revenue. the income elements one services So our are A product. the bona is Obviously, noticed Top and those to revenue, out on commercializing into

direction. services, kind increases, shift portion that which top make up SG&A incrementally as of bona fide in line a So large of those revenue specific the

Could X you quarters? the [indiscernible] figure give for a

I Jason, want. if that, with you could help Yes.

included relation are XX around would quarter, million for for say And incorrect, costs in bona marketing QX, up they -- So months. expenses fide a in the were we or mid-XXs, and X for Again, -- -- sales dialed I around $XX.X from few revenue. XX-something million. previous fees go those sales to marketing were service and so with

those can service So you fide marketing sales increases, patent as bona [indiscernible]. and expect revenue fees and

I Matuszewski will remarks. now turn Jason to call for closing the over back

Thank I results, in We members QX at you looking Venture well results that end we folks for the the And the results great year and had call amazing Medical near sharing everyone, the this term. team today. for success our everyone have QX year. QX a everybody, all all all thanks, night. and the want of joining forward as specifically, an of the as for Well, in and BioStem the amazing to with thank you, had of to

that gentlemen, for and Ladies concludes call. joining. you all today's Thank

may now You disconnect.