PTE - Earnings call transcript Q1 2021

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Operator

Ladies and gentlemen, good day and welcome to the PolarityTE First Quarter 2021 Earnings Call. Today's conference is being recorded. At this time, I would like to introduce our first speaker, Mr. Rich Haerle. Please go ahead, sir.

Rich Haerle

operator. you, Thank thank first and joining call PolarityTE's Good XXXX you results. discuss quarter to afternoon, for I Haerle, am Relations. Rich Vice President Investor of

the Hague, members includes, are Patterson, call executive On which team Interim of CFO. David and President the Richard COO; Jake Seaburg, today

statements I by is Thursday, the date, I'd as prospects due that include in Litigation that forward-looking this that under of that cause required and to detailed XX, Form any the those statements from we purposes the including, to we factors subject like constitute quarter on the XX-Q SEC. disclaim discussion begin, year-ended these statements XXXX current from everyone to participants, XX, only with Any are to for limited today's made to XX-K Safe ended to XXXX recorded. the described today's to expectations, XXXX. statements the report statements not forward-looking December These call and update filed We events the of of under but circumstances law. May speak call, Act that Securities like results Risk as Factors on Form forward-looking Reform may today's would XX, indicated. except Before company's for March, call are XXXX, results or risks the obligation are materially Harbor highlight a reflect remind our future statements and caption differ variety such being and to occur that after uncertainties annual that on our materially expectations will may about and Private of provisions plans to based for forward-looking actual differ caution those actual

on call. the available section to of media the the website will a and replay it via be conclusion We Relations shortly the and following webcast, our investors available in making are Investor

property consent PolarityTE form retransmission the or the written of in now of is the strictly David over call and like David? turn redistribution, Seaburg. is I’d rebroadcast Additionally, it expressed any call prohibited. PolarityTE's to any without to

David Seaburg

our you Rich, steps of over SkinTE, are companies, points a of from to taken address I'll important few that our one to the to is PolarityTE stage management PolarityTE technology transition who over contract by have revenue, proven to begin work in of to of in Hague, Officer, everyone. $X.XX important team hard has our turn then into that review approximately top-line which some every a call past to X, research our the an development up compared on on clinically trial, steps update a biotech to XX%. we $X.XX up Patterson believe results then revenues revenues employees. regulatory addition give will each very QX $X.XX update $X.XX making XX%. million development testing, for stage year million, and includes revenues and is you, stage and way Total Richard into other emphasize the like approximately recap a we direct a patented revenue XX%. proven from a Thank COVID-XX in transform Jake its Chief up were and approximately from an financials. development DFU highlighting at on the company, XXXX our I'd with to with QX, I'm similar proud well to million, revenues were result a development the dedication distinguishes process. taken Financial SkinTE welcome, turn million, for company the technology. reposition by And This successful plan QX. the XXXX. Please service I will that provide Today company, of were the and our were PolarityTE clinically our a a followed our approximately QX, Slide say to

over we that demonstrates SkinTE of experience, data accumulated abundance reactions, zero have First, difficult with from treat real-world SkinTE adverse an and successfully X,XXX to applications which closes wounds.

SkinTE Additionally, earlier we closure, of reduction patient week, as and XXX top-line randomized should we investors asset, data all ulcer from BLA. at is this a give percentage met derisked this primary secondary believe control both confidence area We endpoint diabetic trial, which great XX-weeks. a reported pursue wound foot the a that and

that asset. still per limited a substantial of were a is on consisting QX, enhanced approval. very with sales, is we viable to SkinTE a rep. This significantly a generated which BLA sales prove SkinTE commercially basis commercial $XXX,XXX opportunity, we million which we believe reps, an able In could Second, commercial roughly represents with effort eight annualized of be just $X.XX

U.S. the patents, and interim to the in submit pursuit body in issuance SkinTE intellectual published to see And we SkinTE. and BLA over Philippines. finally, internationally. second of the evidence growing our continues results portfolio this allowance patent that for earlier the with year, recent there on in SkinTE a progress through involving Third, we most and trial, the or including a grow our International peer second-half Journal. for to of in Currently, are of of DFU now the XXXX. of make PolarityTE continue Four, scientific property U.S. two now notice XX continue granted XX SkinTE from publications of publication possesses remain an IND a allowed nine the publications, in Wound reviewed real supports the track to

the address consistent to will period XX, we be FDA's the like ending on May discretion down To winding SkinTE. sales I'd XXXX, with products. enforcement commercial XXX enforcement FDA's period the for discretion extend be of to decision not Now,

of major and expect the not P&L a to commercial with see associated of Importantly, restructuring our our we after efforts, elimination costs to the impact would severance costs.

give provide our on who plan BLA details to from foot on our I'd completed the Richard, ulcers, to update will call development turn Richard? recently trial for clinical Now, like an and SkinTE. over diabetic

Richard Hague

Thanks, afternoon, David, and good everyone.

multicenter that like foot in our of start standard plus participated with by team recently standard to trial, and ulcers diabetic SkinTE, and I'd care physicians alone. the all our of randomized of completed patients, versus evaluating First, controlled treatment clinical care thanking the

at pleased of secondary preliminary standard we're earlier As that SkinTE's in top-line week, reported percent at both over closure with clearly endpoint care, results area extremely superiority endpoint of the this and demonstrated XX-weeks, the that primary ease of reduction XX-weeks. the wound

reminder, sites, a XX a across controlled arm. evaluated XXX treatment patients the in in the were with As XX patients arm and patients XX

closure of patients receiving care versus receiving of X.XXXX. XX% XX% For equating at XX-weeks, the care patients standard of primary wound P endpoint, of equating a standard to SkinTE of alone, value plus had to

in activities. and full as interim study timeline as plans are for significantly much the require accelerate good the near-term to of dataset a to was looking be The which is progress, remain the treatment For Wound IND given results. acceptance used published the patients SkinTE. crystallize We Journal, as analysis future. of to our International these I is the to pivotal FDA forward continuing engaging a complete interactions treatment SkinTE, look our at the commonly regulatory, We're phase percentage patients that secondary trial critical of enrollment some weeks, make believe published and to we and with upcoming were care IND-enabling received company. of team in possible. will our value much IND reduction very expect in application our that results our applications the products the as at single the is as sharing standard important at development the XX.X%. working coming significant standard future arm plus pleased first at track that this to to IND catalysts FDA's We in year, are to to final subsequent to P now SkinTE This submit second-half them we in alone the results, am which we area in multiple the a of currently endpoint, point in Transitioning the care results to and XX.X%, versus X.XXXXX. group equated XX XX-weeks full our most greater from forward of the note skin of for on share the of of process, of It diligently XX the achieve our to the part are for as inform substitute

forward As being to stage shareholder recognize significantly articulate value. a look future timelines we that able complete true become need will our transition to milestones company, and the and enhance clinical and we

to that Following timelines, IND, the the acceptance of and milestones clear our to for plan roadmap formalize SkinTE our we so to stakeholders. a BLA our is

we with submission, and would like and for continue allow of if very as SkinTE, physicians an note plan access pursue us safety outcome will to that serious threatening IND to program expanded allow which, treat to Additionally, to our data. certain to valuable and patients gather continue wounds, approved, part to life I

function with SkinTE approval. to minimally its it's NPFUs, majority and approach, development may space, why we advancing with successful of not that observational grafts, combining structures, can deep variety to data achieve the or our our in wound believe have similar into data, require thickness strongly in regenerate have and HCT/P. superior clinical scarring results and application what are evidence IND is the unique use follicles. a patient's numerous show Clinically, segments an revisit expose split over makes by It robust wounds of and cells alternatives patient retain operating believe gained to directly treatment we as multi-stage to thickness and XXX that clinical Lastly, cases, for full to in or claims, focused polarized worth confident are in BLA, a SkinTE the the and algorithm skin, which a sweat ability conducted three the and will truly while SkinTE durable execute through development we many the skin, experience office. strength, firmly I hair payer and final believe volumetrically we thickness marketing tissue closure. SkinTE to enable BLA split skin treat drive closure, and optimized reasons skin a specifically use, structures, fill for supports is plan. deemed sensation, found by turn, We characteristics by highly-differentiated with successfully regulatory graft, room, of progenitor In is dimensional that clinical important easy the regenerated product. on units be pliability, producing having In from the and real-world grafting favorable for piece clear DFU our from that ultimately as that from such and throughout skin, these us technology thickness, of contrast we as witnessed wound are associated SkinTE studies small is coverage SkinTE briefly utilized complete full tunneling, the critical clinic be also In of SkinTE morbidities is exclusivity The reference preliminary created doctor's unlike that the and believe healthy on a we we adoption, wound vast multicellular X,XXX SkinTE patients to treatments, reducing skin, typically supported healthcare be hard ability important types. provide graft hair that dictated results towards It is extensive a substitutes. RCT and the a to-date, emphasizing a skin the which to widespread our to to and wound and a single applied current the in of are an skin including growth. of core progression, only products cover experience SkinTE native believe provide can requires include exposed grafts, providers to other wounds SkinTE allows skin

the call like Now financial Jake to I'd over update. to turn Patterson for

Jake Patterson

everyone. Thank you, good afternoon, Richard, and

in from refer contract we in Revenues to million products from by for reported sale during approximately revenues personnel, research was headcount decrease million. the the refer the expenses revenues, the first company. from $X.XX of by the substantial the XX, were same three in as period the services, As for reduced three and quarter This our XXX% XX, we from the in and May which million ended as million services in XXXX. decreased million $X.XX Total revenues the for Net operating to XXXX, and costs period month that we quarter total effectuated XXXX, from for in revenues includes million SkinTE, $XX.XX salary David in which to were XXXX. to largely to XX-Q. compared XX% $XX.XX March million, for $X.XX XXXX, comparable reduction services revenues $X.XX period increased which $X.XX the products driven ended and across costs related period XX-Q, March XXXX, of mentioned, month

and periods warrants, million included to March Our month ended million in month operating million increased activities million included for expenses period period million for the The for in period three loss related the ended period the for the to XX, XX, XX, three the The quarter-over-quarter for $X.XX Cash $XX.XX of three of the non-operating XXXX, is first X costs. loss comparable are Net ended XXXX. attributable higher to in operating Cash the as cost. the inducement used prepaid which expenses. period $X.XX loss, December was decreased offering from XXXX March annual in March to cash in fair $X.XX was XX, month from $XX.XX million, attributable for and $XX.XX offering million net of operating approximately XXXX. quarter however, and XXXX, the $X.XX burn insurance. XXXX month ended is common million stock activities value year, in approximately $X.X increase such used losses three comparable to

losing commercial restructuring P&L with be to not we to we SkinTE of and mentioned costs. a David Although, see earlier, cost of will our associated would the severance as impact revenues, expect major after elimination effort, our

with of towards million over equivalents, target, keeping to on of fund cash associated excluding BLA-related disclosed and We activities the clinical believe costs will below operational and $XX.X work David month remarks. I'd our finished previously of per the first turn cash equivalents $X balance Seaburg base the into some for and We to activities million XXXX quarter trials to cash million now sheet David? and the approximately burn, We will cash continue business average. with $XX.X of on back like XXXX. cash working the our concluding capital. third quarter call

David Seaburg

you, Jake. Thank Great.

We are for dedicated to working who been IND have such fortunate talented at upcoming incredibly to team tirelessly PolarityTE, our have an prepare and submission. really

brings I'm enough, the Without all patients, great and Additionally, for team. by thankful incredible confidence commercial in I value done can't that and this stress very work their our SkinTE the to efforts evidence. such in to physicians robust been persistence many never use working a been with an able would we have has to who the this develop real-world SkinTE body of Their invaluable company.

position experience our our company, wounds, with real-world everybody that to clinical Q&A. and treating strengths believe we the the evidence, the for on thank heal and Moving call intellectual our forward as success. to like I'd PolarityTE of a up Thank vision, I'd And like for call product, promise coming for our data now, you. today. property long-term refined all clinical expanding trial body an of open to focus, clinical portfolio, validate including a difficult in supportive

Operator

your comes and [Operator our Ladies gentlemen, with first the Kluska from And at this for Instructions] floor is open Cantor time question questions. Fitzgerald. you. Kristen Thank

David Seaburg

be first you'd knew Kristen. I

Kristen Kluska

conversations reported you the current data you've Hi, questions. question taking week. off for about you this in wanted past, everyone. from commercial first had. this And Thanks on earlier my pricing, based experience to something the recent is because congrats the ask know of I evaluated I a you

also down the So, the been ask a then that's you've trial approval if generated might past, in this setting? off look line, data I had get the based from you XXX at now the wanted to conversations you differently assuming and a of

David Seaburg

question shifted in Kristen, gears in the of learned in because the a physicians we've perspective very is it really past pricing fact product from And the what have and your the the -- of the about was pricing more adopting was it correct? higher usage the Is aggressively. restricting Sure. we when of much that price hospitals point, from that, say market you when certain

Kristen Kluska

exactly. approval a having line? might it XXX Yeah, look whether down you the then through at differently And

David Seaburg

that's very Yeah, good a I question. mean,

clear the very But, penetrate. gears I'll experience pricing we at relationships of and this this learn and adoption notice of the really into providers to to our that fortunate to and ability I'll product. right, about of the We First there really especially real-world was up jump early was on our look to again, was did from add and with everybody impacting adoption, in that can think in and used pricing, were moved to in a and allow the standpoint comment. have very revenue larger that we that wounds. impacting learn sort shift being fortunate were I say, our how trajectory to Richard When really

like, So, very obviously do to to simply, answer this adoption incredibly pricing is I your of important product. question believe the that

that think adoption little have We might to from move will different to in on and a on Having want dig to need to we anything a that? as that closely, a bit we adapt yes, we look very you certain a I in to very future. aggressive But, variables. the have us we allow into going be do something move lot BLA on. think that, lot you of are based forward. we a indications focused pricing be Richard, add into to ensure are pricing perspective deeper to that we as But, that really that's proper that I willing more

Richard Hague

pricing. clinical include, health add that a we think a We would with to that could Yeah, valuable the and think I data achieve BLA, at well-positioned we very that to be of data. data also to that we economic certainly need just generate amount relook very will

total patients, the particular know, price your product. comes cost down of care not of just everything of you As the to

build it to as compelling SkinTE, care patient. cost position to very value hope for be entire proposition in to of relates be able we around to a a the a So

David Seaburg

treat Yeah, specifically, treatment about the are options not all incredibly limited, the and wounds, talked where these are at very difficult to currently in we results strong. very the and

So, we're cetera. treat wounds with proven our these seeing the product exposed in to through experience effective be tandem has in real-world very difficult to et bone really [ph]

us of So, pricing you would able approved have biologic given the seen marketplace, move if an as success point, within the in those to I forward, yes, types be that with for more will, to Kristen, power, wounds. expect your we've we to

Kristen Kluska

think how soon do And thinking for I subjects filing comments to RCT, you made about past the then at trial? roadmap required be you what's ready you've number that then patience? enrollment number into Thanks based about should factor be guided an be in how you on will of start we enroll know of. are the that required the And you thinking to to further know looking around the and DFU think on decision? timelines that. trial. you'll guess, subjects trends the after I elaborate, at of you other around that just I be essentially Can will But acceptance, criteria, but the IND in this XX-weeks. ability don't around the trials you the the going specifically, that see the time, the And if the

David Seaburg

great these to Richard, Yeah, touch do want both two? questions. you on

Richard Hague

Sure.

your or first, one first your answering last So Kristen. one

to this SkinTE think broaden in from FDA. going we an discussion, we're get of multitude what's I for are indication ultimately that a seen gives wound part going a them engage in of to types. of to to the that work us inform is the product. We've yeah, initial type opportunity hoping us indication So And

to remains seen. that Now, be

that going gain about previously, inform sorry, first answered talked some able along is our I be what question that is think what forward ultimately DFU of trial is goal the it your And but where interactions should and need have will I I additional first. agency, to that think from get with we a lines indication, and ultimately to what work the our broader And our forward. hope be I'm complex will first to to us done gain initiate indication. already. I with a going As folks to share forgot we we've will clarity

Kristen Kluska

I'm soon light was then trial? No many to be filing And ready thought start IND for enrolling one asked around saw an patients that the It of questions. in will problem. the this what too how after you RCT? acceptance you

Richard Hague

that. as the to Sure, set for so as stage so the you quickly for now thank Yeah, doing enrollment we're possible. work

We're sites be work that to first to work at taking between have engage couple gap be right steps the need behind hope the obviously all on that to these sites and do most, we that patients our to do So board. there'll being the month's enrolled. scenes and we a the opened IND done of to now aggressive needs being

accelerate as So and plan to of we're hopeful quickly trial that the turnover as possible.

on still through we're of the that terms In sites bring working number ultimately board. we enrollment targets, that on of

As to took a that trial. we about from our past little over enroll fully XX-months XX RCT, know roughly to

-- Now, But of this that our a process. is here folks. pandemic, course, that of possible was was also through to lot for the possible challenges accelerate enrollment do in that everything posing is to our obviously if COVID goal

bringing So, consider enhancing be enrollment aggressive appropriate going what sites. And we we on are take a we're to wherever can. in to role highly very we

other into on FDA issues So, that to guidance take certainly clarity we and to get around patient we account. numbers, as come from have more that

Kristen Kluska

first Thanks. based patients you week, earlier of the that discuss SkinTE? arm? last you the the is XX care compared onset the And then how a this on big year, have the alone focus facts last for for this data of to know the I and question for is could data I standard

Richard Hague

as compared Well, early a I interim in differentiator that for care. standard data shown we've our onset to of the separator critical past the is think of effects and big SkinTE, and in

not the we be weeks. And, coming of obviously, similar a full impact the previously to results. see of I forthcoming Dr. had and about data early we'd on in set, dataset. commented the to that'll the But by full those study. would yet effects, course, that see pleased expect the in complete had Armstrong for similar But have expect reported outcomes very call We would those. was

Kristen Kluska

everybody. Thanks, Great.

Richard Hague

Thank you.

David Seaburg

Thank you, Kristen.

Operator

you. King with we Wainwright. Instructions] Thank And [Operator from question H.C. looks it Sean a have like

Sean King

Hi, I have thank you just for taking two. my question.

the doing you real-world and study as cultivated while design First, hospitals? you you that data to had the Thank maintain better, the and how the would commercial second study, relationship with you. the question, then how the clinical you And accumulated you're that then would you realize accelerate study? hopefully, doctors the

David Seaburg

Sure, first I'll and let number address two. the I'll Richard answer question, question

that make As far the a And the about adoption as worked one develop if to will, who will, really thing this support that of group, relationships of to from Richard I with be We a gentleman are Ryan really a adoption during good marketplace, that group SkinTE build -- relationships entire team that. particular you front earlier pathway are maintaining in to product have the led do surgeons by Jim to of really of people especially sure the some identify be relationships, we we've a team. on they you go for to really has the And well, they're spent got Mathis, have maintain used ways have high And the of that point, because, to products. going as developing that this the better and the the providers, with fortunate incredibly valuable, phase, users, do our are the that your is we've been we're these we them and this working get all focused of had have to and and name. think tirelessly expanded team hand within to Ryan Luciani as really to of of great commercial access. who They're their with if product. in a down name dedicated and leadership [ph] holding, we we lot said, small really and the and support plan to we've fortunate

fortunately, leadership the Richard, for do to base, of plan that intent will. user two? have if done the take has intend out very we our number you we on long-term, you question reach connected the those which make And, do job relationships to commercial and maintaining. every a to with stay we great So, sure developing the team want

Richard Hague

Yeah, sure.

Regarding going this talked real-world mystery remains leverage for evidence, of and not a for a future it that to the to certainly for data, we still look data. regards a potential data with They've plan value for, this at collected, but FDA is regulatory us the have bit how that And with we about any body it them just to we've approvals. good have of data of around and certainly to use discussions company.

to of be it It positive this data ultimately would the point, to been terms speculation of value very as at that So try consistent we're that have. in to guess proud safety But, and what has will we've be. we the outcomes seen.

that, as this with So, the we're certainly advantage we hopeful that we full agency. of discuss can take

Sean King

you. helpful. very Thank That's

David Seaburg

you. Thank

Operator

the gentlemen, you first for quarter and earnings this your XXXX participation. call. concludes Ladies PolarityTE you. Thank Thank

You may disconnect. now

Polarityte (RGTPQ) 14 May 212021 Q1 Earnings call transcript