Earnings call transcript Q2 2023

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Operator

Hello. Good day everyone and thank you for standing by. Welcome to the OptiNose Second Quarter 2023 Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question-and-answer session. advised call be being Please Instructions] that is today's recorded. [Operator

the now Relations. to like would conference to Investor I of hand over Head Jonathan Neely,

Jonathan Neely

morning our for Officer, the as of us Chief the quarter for Commercial joined thank Paul Ramy remainder performance review today Mahmoud; I'm by our XXXX plans OptiNose's second Dr. Good today our and year. and CEO, you Spence. we joining and

in on the be will on call our presented website, viewed optinose.com, section. The slides that Investors can this be

Before conference forward-looking remind during we like that you to start, I call would our discussions statements. this include will

All statements as historical are forward-looking hereby that identified are not statements. facts

Forward-looking uncertainties materially that statements to and by differ to from results are risks could those cause such subject actual indicated statements.

statements forward-looking we note Form in under and website with available our at forward-looking XX-Qs Additional as OptiNose's their is as discussed statements SEC that section and recent at are of that release information the sec.gov, on regarding on issued earnings and today under elsewhere optinose.com. website, most the well cautionary factors factors section the and these risk XX-K filed and

only any You of of of such undue statements. not to speak forward-looking original these any undertake update on The the statement, statements earlier no or date cautioned we during indicated conference this revise and call reliance call forward-looking date this to or are statements. place as in obligation

question-and-answer to will and We move we a session. remarks, now make prepared will then

I that, With now call Ramy. turn will to the over

Ramy Mahmoud

on key I'd a I'd to us start slide today's our into to this moment, We joining morning. thank from to for We'll in Thank highlight us like detail go you, update. appreciate quarter Jonathan everyone three presentation. but listening three. you joining takeaways for more and second you like

that nasal CS of be data the as is of launch, for providers offer for able XX a than by and remain engage the additional to preparations health care chronic ready least currently in the at polyps. as first market we indicated we enthusiastic potential sinusitis. being and about diagnosed treatment frequently to value only research First, being suggest Claims product more times XHANCE

care where products is by multifold access and the could branded current new enable increasingly larger off-label growth environment, use to us therefore, indication the believe we patient for a XXXX. In in health strong payers, drive years multiple audience constrained starting of

high-cost that We current XHANCE treatment their desirable, may facing clinically proposition could economically both who or be or also symptom and the believe biologics. is for offer, value otherwise patients injected dissatisfied burden particularly very surgery with with

drug being more now in target indication for new our FDA now. February XHANCE than the and in the period. through goal halfway new supplemental the of FDA with review is December, we We date application our Second, reviewed submitted by application are

quarter XHANCE and continued sinusitis. the strategy, prioritize rooted which for of how launch to only near-term in second will effectively of value potential communicated against treatment chronic of Third, previously our in to is year, the drug in investing intent the you have the we we execute show the FDA-approved XXXX first operating our

patient to a differences, of the on return potential than of like we from you I'd approval, for a point, important remind return believe polyps. of investment last this as on elaborate treatment promotion XHANCE promotion there the greater clinics for available prevalence, payer briefly and are including nasal make that To following XHANCE significantly sinusitis that dynamics diagnosis, frequency potential from

of careful XXXX. profitability chronic while we XXXX increased being focus sinusitis this, of have successful to materially cash in the and to business Because for capabilities of in that the infrastructure be on preserve structured will use reduce important and our launch

the through than results this our initial and are better that to strategic half expectations. year this of discipline adhered We first delivered

increased our of result performance, a year have XXXX. we expectation full As that revenue for

of be approval are number future by product are chronic believe polyps. for can we and four, of patients magnitude the at data increase CS of to the being sinusitis XHANCE nasal the whom FDA-approved with slide being first patients promoted medical currently more has for diagnosed diagnosed as that order to treatment least potential only Turning because with indicate claims XX-fold that

with our new The for see strong growth opportunity numbers create would indication largely of commercial who large to within footprint, promoting existing specialists diagnosis. patients the

exploring selling would expanded facilitate future commercial and our by patients other outside models and those patients ways patients. physicians are to we partnerships, commercial and universe outreach include current newly reach, of for alternative cared The to also actively physicians

quarter, an the is XHANCE chronic This supplemental any previously a accepted previously, in which for six, for indication drug agency second indication Turning we that slide our treatment application announced rhino sinusitis. never new has approved novel FDA to the of with product. drug the of during pursuit patients

original what's on efficacy ongoing. based safety date, year. submission been February, is of in application clinical FDA substantive And goal mid-December set Focusing this largely next, review the which is of the date and this for for has action on the

Our to throughout will focus so regulatory review the responsive continue to continue do during and FDA review on entire clinical and the being teams to the process.

Turning to slide eight.

objective our our XXXX trends is in stabilize to current demand nasal reduced with footprint polyp materially reduced business in and reminder, a commercial a expense. specialty As

effectiveness launch and for XXXX. resources. in XHANCE launch set best successful and commercial necessary is the of operational preserving to CS our for This both capabilities of improving intended up us While efficiency

objective prescription XXXX. in we that of second With demand the pleased quarter are results mind, XHANCE in by

demand. there second were XHANCE, quarter approximately over of Regarding quarter X% for XXXX, increase of new X,XXX an the prescriptions XXXX. second prescription In

measure of prescribing by physicians who the the to quarter In depth XXXX, approximately compared of were XXXX. of second filling of physician prescriptions. patients addition, an breadth the total of XHANCE there increase for in and We XX,XXX number quarter prescriptions have total XHANCE X% about second

second Regarding XHANCE, who of breadth, least had at XXXX, in of of compared physicians quarter patient increase there one second XXXX. prescription of the X,XXX to were a an fill X% quarter

XX approximately from decreased quarter second than had prescriptions second physicians to now X,XXX physicians. more XXXX who approximately at filled their quarter quarter, number a Regarding in depth, by X% the by XXXX, patients number that of

part based parties also in us monthly to slide reported data I'd the like and, preferred pharmacies pharmacy inventory the all on on directly part, network. third and estimated on to that that large data in by are of XHANCE from note prescription is data part this

also I'll that XXXX we're the second quarter our note data reflects methodology. that XXXX current today showing

reference, methodology. we've For prior prior footnoted based on our estimates

financial I'll second now to turn performance. Jonathan our the call discuss over to quarter

Jonathan Neely

Ramy. you, Thank

to Turning slide XX.

financial shaped the prioritize chronic for FDA-approved potential are first results. the second by quarter drug encouraged XHANCE resources of treatment to our XXXX ever for are capital as by We strategy They our rhino sinusitis. launch

recognized SG&A the in $XX.X that of second a XX% plus R&D is OptiNose $XX XXXX approximately to earlier, of million. or XXXX. reported compared million second of we expenses expenses quarter decrease quarter As This $XX.X million

stronger OptiNose $XX.X net for revenue, the is XHANCE million. of revenue This quarter revenues recognized XXXX, the our quarter. a Regarding second original in quarter second million to expectations of net second decrease XXXX $XX.X than of compared

It is important revenues guidance when were first what we we than to XXXX the for $XX.X announced stronger note our expected year. half of also our that million initial financial

have by second of Net raised a in year year-over-year have insurance of deduction. increased in their programs, in will does The XXXX that in factors, XHANCE an met patients with few management number a discuss gross not revenues, a co-pay our is I in we of result to to which decrease quarter volumes which of increase or the commercial volumes criteria the guidance as moments. including attributable well the net increase an for the proportion not revenue to further XHANCE as increase range in insurer cover attributable utilization of assistance full proportion government XXXX driven an of Accordingly,

I program to revise some in view the segment a of will co-pay note assistance demand for demand profitability. we uncovered strength patient within way that that commercial an is that our strength prescription opportunity increased modestly the exchanges

data data decrease Finally, parties estimated XXXX. available XHANCE of $XXX, revenue from pharmacy received XXXX from on purchased to preferred estimated a second our on inventory compared prescription quarter network, the the prescription $XXX second the net per we directly in was per based quarter revenue of prescription average third for and of and

quarter annual that prior And increased results revenue net compared per in XXXX are revenue is for prescription. and expectations here our per with net consistent important is the to XXXX pattern. of What XXXX, overall these line expected second our first quarter substantially prescription with

half reduced operating results We align in with by XXXX million our when expenses first continue first to intent Overall, our XX% XXXX. cash of in to the compared or half use half XXXX. $XX of reduce of to first the

demand we XHANCE this be achieved expectations outperformed product resources sustaining and in maintaining enable while believe of our indication a will that We potential the launch and a new successful we necessary capabilities revenue, to for for XXXX. and initial

XX. Slide Turning to

our than initial mentioned, were the just first in I XXXX XHANCE As of better half revenues net expectations.

year of result expect between have performance, million. for to increased XXXX. we $XX now revenue be $XX full a to the XHANCE revenue expectations net for As We million year our that XXXX full

we important XHANCE Previously, million. CS assuming launch in our note between net that to $XX It's year and from to full guidance. expected are revenues $XX revenue a we not million XXXX be

net per of the we the pattern second through first prescription, typical In addition, half half revenue with respect to our historical XXXX. of XHANCE from expect improvement

revenue expect to for per year be XXXX. the average approximately full continue net prescription our We to $XXX

which $XX to approximately defined continue range expense expenses we be million development general and XXXX for as and the year Finally, $X million $XX research the of to million compensation. plus to operating sales, from of administrative expect full stock-based in

Ramy? turn will for the now call back to Ramy closing I over remarks.

Ramy Mahmoud

Thank you, Jonathan.

has questions, months reiterate the years front of and believe I the on our the future. opportunity potential into like us, in the Before coming to take business which to reshape moving in to of I'd significance for

only profitable We increasing treatment business XHANCE sinusitis and allergy an revenues as for to would and net our believe chronic leveraging existing an opportunity first build us give by and for focused commercial a indicated the capabilities. of approval ENT drug

specialty In can to exploring beyond own in infrastructure. we partnerships I our largely value on noted, we by engaged primary commercial in are create shared current our the actively segment what create that's commercial addition, as previously care

for morning to your the like attention for and open Q&A. this call I'd you that, With thank

Operator

line [Operator Amsellem comes with Thank you, proceed. Sandler. from doctor. Piper Instructions] first question the David Our Please of

Unidentified Analyst

seeing after how expansion? for is expect follow-ups? payer to upcoming couple at to net And and David. terms do nasal change are landscape evolve A prescription evolved you of additionally, questions. to speak this the Can expecting recently And Skyler prescription limit payers revenue with expansion to per whether all the label of the you CS? Hi, us on in you it's

Ramy Mahmoud

and like answer payers part the maybe the revenue. the of address to question that first you'd around then Jonathan can Paul, about question

Paul Spence

any Thanks We change the that and Sure. landscape haven't related polyps. really nasal coverage with to in for XHANCE material the seen question. payer

our of prescriptions deploy as demand well as commercial continue efforts authorization fulfillment there. to And so in we the our increasing prior to efforts optimize the

that that, optimize sure expect As forward we also to we've again, CS to And our with is continue similar continued look there in our to there. and access the with a will efforts commercial we make launch, fashion. payers the the deployment

coverage. So answers hopefully, your around that question

Jonathan Neely

Okay. think prescription. But at XXXX contracting just written on you to keeping cover guidance expectations mind, payers, don't many And is where commercial the in the from, revenue on particular, Skyler, on revenues per our have contracts for for in our we or our terms of the space of place of in indications in label business are coming in any our the look product. I with most when today

going if And is contracting to so similar or written that approval in that future, XXXX, that chronic applicable into roll those a we to we sinusitis as CS the an prescriptions have of indication. be for have we place in much they're in anticipate, the today we

revenue our that was we for in are think $XXX year, full approximately reported full prescription aspects year, come $XXX year. the year. future. last I I that But for we prescription just there expectation [Indiscernible] revenue this year's are the really for to per this Then a not expectation into below bit at think of something expect And the per

less We anticipate to be going on year, inventory. appetite was there that the to hold this side slightly customer

were look prescription year that, expecting downward and per of $XXX. going think that this us be at would year-over-year the when lead that some a a revenue basis, of we to was approximately pressure we to And so on I

in a us headwind of and repeat the would being But the terms won't arrive of for future, itself at, there's be into inventory something there that we'll that is I that's think future. in that level a something --

of per prescription that So, improve revenues future, a future. over he we opportunities net I'll With turn into be will to if think but has help to it either there's revenue the back that Ramy think summary on I the those. to us any net see going remarks into that,

Ramy Mahmoud

feel the of we involve And XHANCE. the No, does of coverage are is I'd to reiterate we just I have part that before, to for which out which like a polyps. frequently we indications, prior nasal said meaningful FDA-approved that coverage like just authorizations, today there's have guess to course, that pretty good indication today, restricted as

same Paul be sinusitis. in As chronic of inclusive wouldn't said, of coverage indication future, that new the

engaged of in part very have first this conversations We through year, transparent. being with we're payers the

similar And expect today. going we it at Do quite to any questions? way be to we did least is into And our XXXX, answer coverage questions? additional the you have your

Unidentified Analyst

Yes, that super launch doing helpful. label color expansion? in. question additional on was one just any the could the preparedness If you sneak I provide ahead separate you're Can of

Ramy Mahmoud

you preparation for to actively Paul, are as comments? might expect. would make in like any launch, We engaged the you

Paul Spence

sure. Yes, Skyler.

that fresh launch. the only positioning rapid approach of so for XHANCE prepare a So will uptake. indication enable that a we can and on that new fully and product One we're focused is positioning we're we that messaging as taking launch we and seize that first things many the

But pharmacy distribution with retail of we're setting scalability the as the also infrastructure. pharmacy ensuring network. both well our That's as within

We programs. look affordability continue at payer and evaluate our to and

get can and said, to for make efficiency while patients selling our and care health launch. appropriate also refining opportunity the We're XHANCE Ramy we at P&L. larger promotion nonpersonal as to our the targeting overall direct model access So, provider sure our assuring within our access both can

promotion And continue efficient outside current accessing options to of audience. opportunity our the then lastly, evaluate we HCP for CS

to we launch a So, in will be and get just position continuing have we're us that ready. things are we for several think ready plan as that launch put these to

Ramy Mahmoud

add can a just I comments. If couple of

expenses the it we as launch today. go The our with as operating expenses we've first is, said to is operating XXXX similar the the before, associated we intent will current into that have be

audience in be with have to a we not don't launch precisely but the today. them association we're to same to with may expect increase launching similar they largely footprint same, because So, we the materially the what

our us comment I'll is opportunity and that actively our we to of any primary pursuing with as additional for launch, the care make space are questions? who . can the allow planning care reach you incremental of access partner associated primary expand have part Second into mentioned I earlier, the that. possibility Did a as the

Unidentified Analyst

the No, color. that's great. for much Thanks all so

Operator

[Operator you. Instructions] Thank

Ramy back further will for questions. Mahmoud pass All don't right. any I see I it to Dr. remarks. final

Ramy Mahmoud

heard thank to us potential like this morning. enthusiasm associated I'd for date our upcoming Well, you've over with the Okay. joining Hopefully, approval everyone our in December.

perform against that quarter in while we're year the far XXXX and continue with And a expenses product the look pleased potentially fact results to execution underlying expected. forward so third filling bit on We our and demand. reducing this growing to as you hope little stabilizing strategy, our exactly we'll even our

Operator

Thank and you all for program disconnect. conference. today's now participating does conclude in This the may you

OptiNose (OPTN) 10 Aug 232023 Q2 Earnings call transcript