FOMX - Earnings call transcript Q3 2020 | Foamix Pharmaceuticals Ltd.

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Operator

Good day, and welcome to the VYNE Therapeutics Third Quarter 2020 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Michael Wood, LifeSci Advisors. Please go ahead, sir.

Michael Wood

you. Thank and joining everyone this you thank morning, us for morning. Good

was SEC. of let from begin actual could intend, described in and well you difficult that contains Company forward-looking progress, with uncertainties conference prospects the could we differences performance. involve current assumptions And on speak variations me not optimism, the in no forward-looking morning contained statements call, forward-looking those update cause satisfaction such in date as to the the such of Company the after forward-looking. statements, Several absence by and this to formal supply release information Such words, statements information Before the with differ call the circumstances of but the and this or regarding results guarantee that predict. statements factors any only anticipate conference materially publicly new are is remarks, remind Words These that today's does are that this obligation such express expect, as the detail of statements forward-looking identify that press risks, undertakes release a are that statements. not in to that issued the believe, and or projections similar the and and filings as with plan, contribute press Company's forward-looking call. reflect Company's as their not or some statement mean

turn Chief Officer; Saik, go call of VYNE please earnings ahead. Company the has such reconciliation will are this I'd Commercial non-GAAP portion call information. to include over numbers Officer release. like The the Matt morning's Wiley, in for financial Executive Domzalski, call addition, Andrew Chief Dave to Dave, At In this a Participating time, Dave Domzalski. Officer. Chief certain Financial of in the the provided Therapeutics; and financial

David Domzalski

value corresponding It's corporate everyone. our commercial to stakeholders. this technology. since Having and take is and good rebranding ZILXI, behind wanted a our at ticker AMZEEQ was you, thought this Therapeutics announced morning our meaning branding and a VYNE Thank opportunity name our of two to to and achieved for proprietary look aligned we the to call The good customers symbol to first the strength, and to a with a that symbolic resilience, our products various Michael, update sure reflects image our with our was to make quarterly growth, and approval September, FDA we positive VYNE. our testament of our and vision endurance core project values, our new we also in

which lesions to approval in We are FDA fact, is on rosacea. our rosacea in approved the in first the X.X% use ZILXI for treatment minocycline for of October is form have received product topical of form be launched to ZILXI for inflammatory in May. any We adults. in excited Xst, this minocycline And

drive rapid a remains seeing are patients. new ZILXI out our for with with signing acceptance. from an of unmet and market to Scripts broad already payer with on the just ZILXI option a and should gain ZILXI medical Wiley the launch, area Matt broad we that and of this. just already treatment a technology leverage significant trial believe availability need, front, expand The as care will AMZEEQ providers of Our of excitement experience are launch. to payer we health after few on relating work revision the with gate well immediate right Within in progress to Express as weeks for receive as contract priorities the We experience MST and made to ZILXI order reimbursement. physician acceptance of

blended overall and report eclipsed market The market AMZEEQ that prescriptions levels acting monthly and both we weekly pre-COVID continue pleased have Turning I'm to and March then shutdown the now gaining to counts share. are for recover continues to AMZEEQ. for the time since in now grow. prescription to first

that enthusiasm see way We were of performance hear expect that to therapy utilization and a they also AMZEEQ could health care plan broad their Xst, and October in to were Also utilization of both believe currently practices. in these doctors ZILXI they among acne. dermatologists, to shared continue interest providers become trial which doctors which three ZILXI we investors to how the using continued AMZEEQ and They for patients increase. continues We highlighted as delighted hosted symposium use the of pleased first-line polarization. physician and are these that on AMZEEQ with the in featuring AMZEEQ in their

dated form, miss registration the can the event, on you and can a view be the under section. If go replay. to Events the website our October event, fill XXXX, section, Simply X, and symposium vynetherapeutics.com found replay the Investor click on investor at physician you the Presentation

Regarding is combination, our and moderate-to-severe for foam acne. minocycline FCDXXX, which investigational adapalene

X how success patient X along trial, end lesion treatment with showing counts. plan for our results meeting quarter, IGA inflammatory X FDA improvements and a Phase and Phase June, we potentially announced best-in-class Phase have positive this in Recall both with the intend development in of data of Phase the will that X We score our XXX program. to share

on will We're update launch Finally, now Wiley, an LePore as His strategic products science a both for in me that, to CEO to to grow the our announced creating in September, the as value, and our member call have we commercial of will of to appointment Board shareholder the and Officer, let commercial our our execute who helpful provide several over business. our Commercial continue With enormously an our extensive of on Directors. turn Chief activity. former experience and record M&A be Matt Board. life organically has we companies. Pat Pat thrilled Patrick a Board of of

Matthew Wiley

Thanks, Dave.

launch execution the market. rosacea We AMZEEQ the into are of the commercial with pleased for ZILXI recent and both

Although resilience our of on the AMZEEQ impact the XX,XXX over the team and encouraged and XX% to volume sales physician in to both quarter growth continue access has obstacles. fortitude our acne XX% market representing at QX, and and NRXx prescription for had sell-through by third XX,XXX respectively. in these team, I'm TRxs, pandemic came the

Additionally, in X,XXX our most recent weekly we for time. first equipped the TRxs data ending of XX, October the week

XX% expand exceeding quarter. the our We prescribers, trial a continue over representing with previous increase number unique to reach through of AMZEEQ and X,XXX a QX, of

educated practitioners and With total the one of respect of increased and to XX% process. PBM ambition to XXXX. since features health the X,XXX on AMZEEQ and of over AMZEEQ healthcare with major access, X,XXX in speaker coverage market care for programs commercial covered launch, lives Additionally, live virtual with we've negotiation providers through our approximately total benefits has educating

our to XX%, is lives negotiations been which commercial has the to covered goal Our end before of complete our over year, take the would target. which

just to unmet appears the Xst in Turning of prescription through formularies. to the on follow as in ZILXI Conversations our National calls commercial over encouraging, branded lives XX% one of Flex educated made month ZILXI, payers it nation's peer-to-peer rosacea to the population. ZILXI XXXX October date. broad strong the covered rosacea additional ZILXI X,XXX reached to the launched be on made effective is contract significant the already these XX% recovered over in cover and on interest and continue formularies. coverage, brand the lives over successful this payers Preferred, We've a important ZILXI country. with that care largely the step now commercial in have represents X, programs need Scripts, with have leading Basic and covered toward acknowledging This October XXX With we decision universe market Express impact. to with its from of U.S. of success -- millions expressing PBMs October. this with health across providers an execution, was COVID-XX payer target of

expect We the to now who provide the over PBM to next months. execute additional Andrew, will will updates. call financial over turn I few the contracts

Andrew Saik

the program. for review period quarter. in revenues Matt. of cash totaled Thanks, ended position quarter million third will access Revenues and our XXth X-month the about the September talk market In I my costs and financials, quarter $X.X our during the

million out has program. for patient we access leveraging a synthetic done temporary always broad and during program that product. to X insurance months This while without our the associated anticipated $X.X of on Finacea revenue AMZEEQ $XX, the acquire AMZEEQ Our pursue we payer from our XX, with million royalty our revenues and $X.X September been licensed of primarily to strategy product LEO the revenues Switching for commercial unprofitable product launch was no access, sales, ensure access of phase ended And this Pharma. to Foam, allows of coverage. consisted XXXX. were There coverage market predicated eliminating patient a

be with stages program the we of the to PBM, expect are in half we that one large negotiation remaining first will end in able we of the XXXX. Given this final contract that

With and of over believe we $XXX from prescription. be pay range per comfortable first feel tightening to XX% sometime value the of elimination per commercial the realized expected covered half $XXX this that anticipated our option, of the lives per prescription $XXX should We having attainment $XX $XXX cash the of to prescription in net XXXX. to

investors and earnings provide on our and XXXX. XX, provided equivalents to to for our cash and numbers this a from the going make into and projected We our for estimates. results adjusted in through Beginning this quarter, are cash believe it provide non-GAAP begin cash, analyst with September We’ve end and We of as believe easier to of million basis. totaled flows XXXX. will investors million $XX earnings transparency that non-GAAP Our compare adjusted revenues our the our both investments GAAP runway better release. $XX reconciliation earnings cash showing we GAAP

quarter share. per of quarter for to When $X.XX the was XXXX or or XXXX. Our was excluding million adjusted loss $XX.X period $X.X or per share $X.XX compensation GAAP expense, XXXX third net $XX.X our per share. $XX.X This loss million in stock-based million million comparable $X.XX net third compares

adjusted third to $X.X $XX.X operating operating $XX.X expenses SG&A million. compares This adjusted of million $XX.X which adjusted of included expenses R&D the of quarter, million third adjusted SG&A goods $XX.X XXXX, expenses including million. R&D of were quarter When for of adjusted For for million. expenses million expenses quarter and and were $X.X of XXXX, the adjusted of $XX.X expenses of cost excluding million sold, operating the

For both of entirely considered expense. non-stock periods, adjustments consists compensation --

operating and the restructuring anticipated would costs trials restructuring, indicative forward. expenses our structure for and cost X be and $XX one of million required to not do Phase related FCDXXX. into of other combination complete approximately now are going more costs QX should be the but Regarding Menlo, the cost the of incremental is We include per future, believe sustainable that the that quarter for Foamix our

in stock-based compensation the to of QX, XXXX merger; were goodwill related contingent non-cash ended expenses of of our to million share. in $XX million operating expense. for our $XXX.X million When the period related adjusted million consisting non-cash to loss to net QX $XX the impairment period the expenses X-month value and items, September $X.XX net and Moving net million $XX was adjusted IP in Menlo XX, R&D or which were these loss and rights, million loss respectively. related converted $XX $XX a GAAP excluding of Included million, $XXX

Our unchanged current million is XXX shares. approximately count share at

on XX-Q our please Form details with refer the full our to For financial SEC. results, filed

David Domzalski

prepared Thanks, That concludes Andrew updates. detailed our and Matt right. for remarks. your All

questions. So, operator, we're any open happy for to now call

Operator

Louise we'll Chen And from Cantor. take question Instructions] our [Operator with first

Carvey Leung

Hi. Good on is Louise. for morning. This Carvey

Just a here. questions few

of -- all, with the remaining coming what on last Secondly, some the meeting your the R&D plans for further quarter. scenario major the up much timeline your X negotiations possible PBM, the merger you. FDA what plan of progress costs? are in Phase serlopitant And after scenarios is diverse are level? FCDXXX Menlo? your the to there Thank with coverage development First would with from causing completing and each increasing lastly, How fourth impact any

David Domzalski

two your Thanks, Carvey. I'll last some on thoughts me, questions. -- provide excuse

all, of regarding serlopitant. First

in direct few quarters, right past any the we're stated putting investment we behind As now serlopitant. last not

to ZILXI in and -- asset. an progressing discussions AMZEEQ We any with for being of obviously that. execution have as partners. we're imminent open FCDXXX. certainly value to well it We’ve the as had at there said, that’s we potential updates on to all on is launches is focus past the our believe nothing provide and So That have

this at obviously, assets in focus, Our the FCDXXX. investment commercial is the again on and, stage

in a around It the is what believe, a best-in-class positive obviously, have the so -- then But in is said and quite of X We Phase significant body the that of your acne. of from safety go program you program were in X on we'll could said for the X a going FCDXXX of dose a the two variables past, Regarding treatment vehicle-controlled is there's a half FCDXXX, first you one bracketed Phase is concentration Phase the plus very AMZEEQ minocycline clear that a depending that FCDXXX But double-blind, year. X% in said -- I as AMZEEQ lot past, would be of X a put minocycline product are an X and moderate-to-severe ZILXI. ZILXI. next Phase us Phase this as to ZILXI require such the X% And just studies. on meeting studies of a and And know, shared, X standard a of the We sometime end on outcome, safety We're initiate do that. with of track extension. potential results. I've dose of It's work be to that Phase requisite Normally minocycline, or we in of into is AMZEEQ guidance has or as the to there outcome would quite for light a a assuming dose of as data We the We current AMZEEQ, And which from quite as assume environment outcome quarter. X we the the those dose is the that pleased of have will concentration program. the X.X% and study, the open-label the for pandemic. for minocycline. Phase programs that the replicated the encouraging. in dose acne. dose be FCDXXX. of between believe in a

marketed that's the a product, best which marketed do significant products there with in data FCDXXX to have safe. minocycline adapalene there's which the and -- yes, for dose is is X.X%, the So, for of out body the is for adapalene for

It's possible. a be. together ultimate this design team internally the we'll of put there. And if We'll vehicle-control we terms going later we'll from have should it has done the see from a NDA fantastic have So that Phase roughly the or job But that's foot goes for full comprehensive just two then expansion, meeting again here an in a as roughly months view initiated. what the patient We'll safety review. end. roughly that FDA. factoring later for to this take it timeline quarter, quarter. first time best of the design X from how studies, obviously forward do program, know We're so we absolutely to VYNE at comprehensive and package XX our double-blind to plus program the beginning open-label as to is efficient XX And XX-month an putting it

of to say X plus But full And out those see a concluded spread what program as is outline program the meeting like later cost the XX an So after quarter. we can XX out our as X will this of over million go. period. program are, how we year the time long FDA kind sort look ultimately with we would Phase I

I coverage, regarding to Matt or turn over think it Andrew. I'll

Matthew Wiley

morning, Carvey. Good Right.

really comes remaining we do down it under And from forward. contract. that the So what pull-through about after the we PBM is point get question to

that's in contract we did underneath nod last get that to plans deal, we'll the we plans We we that sure take PBMs that's one coverage that's plans last contract. now to I probably being had symposium seen and able of under and formulary are custom and of they well. they about have the those the when today October. the that with the back pull-through under So and do after XX% of major the reported things to XX% certainly that a options to already what you've custom between have we we PBM the as some payers time have think And working continue they as underneath aware that blues make the a the

Carvey Leung

so you Thank much. it. Got

Operator

to ahead. to open. Next David you will with line would move And he's we move not like Piper David, is go responding. Please Sandler. your on, Amsellem

David Amsellem

mute on me? was actually. you I Sorry, Can hear

David Domzalski

Yes.

Operator

Yes. Go ahead.

David Domzalski

Now hear David. we you, can

David Amsellem

Okay.

that. about Sorry

thoughts been to topical. do going on ZILXI to going from. where patients doxycycline patients These patients some Just who or think to wanted tetracycline are get who you're pulling naive have patients on you are who be be on or other to doxycycline

what the of the for think AMZEEQ. a to do mix ask be? get I'll trying kind you question maybe will of And same Just sense patient

from to think the naive and you you extent particularly getting patients coming go where patients? treatment If can are Thanks. mix, through you're patient which the

Matthew Wiley

Sure.

let with [technical the So ZILXI difficulty]. me start

yes, we metronidazole displacement So ones be We beat good two on Finacea. of of metronidazole going the such see and other further primarily [indiscernible] But study this products you've get world. pretty from primary got the demand we're doxycycline. from yes, doxys would And the and the and that one. a down as our obviously to list,

relates As it to market. we're broad disruption seeing in pretty the AMZEEQ,

been of taking it we certain So our today. It's market but to we're are to expected a from whether we as has products displacing everything. being bit products, it entry tough discern added pretty certain a or disruptive data, from

David Domzalski

to that and you’ve in -- I And what arena, doxycycline and of in antibiotic Matt rosacea. of two [indiscernible] then therapies treatment biggest would where we are the from terms the the as David, add pull is they're the too, metronidazole, outlined, minocycline. ZILXI, potential Yes, the the and utilized business anticipate outlined,

over there's of for written rosacea. the treatment For million a Metronidazole, a year prescriptions

research. in play launch out. market have the in we're we the and see research how and from AMZEEQ we Obviously, encouraged early we're research both that certainly consistently But to have from the in very ZILXI ultimately So seen bit launch. products out these the outlined, to by potential disruptive, continue going potential the things as broadly. what see months be the obviously we're Matt to we that have And to we're on to seeing see we and And shake it's gain traction share how then X more pretty a drug. as into we're AMZEEQ, ZILXI eager a launch very,

David Amsellem

may the you to expand or And that your franchise follow-up some do gets make the could acne conversion a you then regarding market, is of large a your what helpful. expectation which and extent That's -- to question cannibalization. if Okay. extent the expect to I XXX footprint just bit

the of more or conversion is expansion, Just a this a trying of combination sense the extent get Thanks type if to again. to really of paradigm. product

David Domzalski

David. Yes,

So I a look this welcome as at market. to addition the

a So need just obviously AMZEEQ [indiscernible] monotherapy. they who to patients versus be certain fine going to combination are going product are with

going And so it. think thing those certainly the to giving is a -- is right to be FCDXXX the way to choice think addition. a think great market. market, I it's products, the in changer to for We about the game the right going be

was have work of optimistic think it's overall. market. market to disruptive pretty market the its it the we the do do research to with chances, the to some for equally on But current about disruption impact us market. into the we going be we've market And that ahead the feel AMZEEQ in understand given So as and what had we coming AMZEEQ seen research

David Amsellem

Thanks. right. All

Operator

Mr. David, done with questions? are you your

David Amsellem

Yes.

Sorry thanks. [indiscernible]. Yes

Operator

Next Cacciatore Ken next move we will Company. on move to and we -- Cowen will with on to and

Ken Cacciatore

guys. thanks Hey,

got could you but came if couple just on that like this a an of I I could ZILXI looks when you I a CVS, be managed late, on maybe are saying, done. gave sounds quarter, hear on bit on, were AMZEEQ. know wanted update care like just timing to it little outstanding finally So we still that match questions. you but

at all have that be coverage think lay then out capturing math, ask breakeven. ZILXI kind And the going of don't us, X.XX So a for is for is on do get according still do X,XXX a coverage matching out. to guys get same, you need you just roughly to could if to would of lastly, to kind per you my doxy. of at when me angry things normalized pricing the until shake kind to about to wondering bit to because and for board math, little week I'm then, combined AMZEEQ, net pricing once And of you but ZILXI and AMZEEQ we'll going when X to you're prescriptions

you internally about As look rate? a Epiduo an when that Axon individually. guys just AMZEEQ, at they're of run wondering, XX,XXX model inferior an will Just products doing think do you I and to to week, type XX,XXX

You franchise. have a combination

investors getting try on in prescription stare numbers the of So think not run of I debt kind managed available pricing and I with right? growth, on my board capital balance terms numbers you, equity. And and that if just and net just a of negotiations we're threw know care lot you as sheet at the of to confluence are basically rate, at necessarily then to a you. good would markets be do the

a could down, sheet. So help chew to if growth, stare and of managed at balance but care your they as Thank see investors you the to lot you. confluence wanted

David Domzalski

Can that? you take

Matthew Wiley

Sure.

So morning, Ken. It's Matt. good

know timing their PBM There about custom We to major block the engaged for as we've that so market for all across months. first conversations plans. country. PBMs a the X of certain good most all, you are the and had require Regarding that with PBMs smaller date. to for we've very new the feel of ZILXI,

now, year. a quicker one in we're that done in So contract than get a with get the had pretty to optimistic able fashion AMZEEQ, can we course AMZEEQ, major given a we similar timely the feel of but that the coverage window we change to to were these that during and PBM

been. has this a So good quicker than believe and the be we feel about timing we little that should AMZEEQ

Andrew Saik

your we've sorry. we expect with far David, to off. $XXX of math $XX, your isn't given sure. expect to similar To relatively your would be would Obviously, about guidance We the Yes, prescription. ZILXI question, regard math, And to per AMZEEQ.

products is price As the both same. you the know, WACC on

be a want precedent. We we on be them don't two. As them we switching priced to payers, between pursue have indication. obviously want disparately the to We don't want coverage the because we with

them to best our price parity. doing we're So keep at

correct. your I So ZILXI I your think assumption is for math is think pricing And correct.

As as our timing you to forecast. on our know, given in the haven't we timing, --

So we allow traction Matt simply we think believe products as project out. with would to we quickly I our and to that need the and I Dave are the in market in agree and get But the can. you will you I agree, superior game as

Ken Cacciatore

so Thanks much.

Matthew Wiley

everything, Did Ken? we answer

Ken Cacciatore

You did. Thanks. thanks team. Yes,

David Domzalski

Thanks, Ken.

Operator

[Operator we Dolezal from LifeSci Capital. Instructions] Next will Patrick hear with

Patrick Dolezal

Hi. Thanks questions. for the taking

question Just start a COVID-related with. to

should are As there's areas is to beginning the territories -- restrictions some in particular to tightening of expect as or rise then been winter terms certain at particularly just in predominate similar active this note, and cases trend country. on I organization across general the what the year coverage new that of board. point, in market? I'm if the you’ve a seasonality, mean, just curious of Thanks. with by approaches. affected And we continuing very even kind adversely

David Domzalski

Patrick. Thanks, Sure.

And unknown. certain You of the a when follow-up we'll over our big we've on this and the the of obviously questions, a We're sand hit about profitability Ken's of the consistent to cautious response know, environment. COVID, line putting in the because couple mean, was I the like, as just been last for regarding current marks uncertainty is quarters.

In cases, geographic deployed living part, is it large with. rules precautions. there. varies field the we're cases offices remains where obviously spikes the are arena appropriate a region. as with got But around the similar by regulations others. is much are in past than Matt, representatives this more access, And, areas think color. we fully shared there open where various contend open in appropriate country The I but and There's have in the geographic again, obviously more to have open we're spikes all can from still I've getting not pretty force provide a everybody in our that certain and in macro that calls more earnings we've seeing taking areas little access areas global that

more in pivot office where as the quite that's this continue more reflected think unique of on well increase to our all restrictions we both And the numbers continued the call so subscribers. again, that, manage we that as presented virtual there's of pleased top of we I to at efforts And initiatives. number our And with headwinds, level, despite the team. growth, in prescription in we're

manage like So, any company yes, we're continuing other out this to there.

needed. efficient I more and provide think I'll pretty turn we've some environments proficient Matt And to pivoting over to at additional to it as gotten virtual color.

Matthew Wiley

Sure.

let start the the healed markets COVID-XX which themselves, regarding me rosacea So impact. with since market, has predominantly the

We diagnosed patients to, in the were and of where number not have rebound seen QX. significantly early if volumes similar of they ahead NRx

QX space, TRx we it versus acne look has the coming XXXX, the if but Regarding been down at about volumes, nicely. XX%, in XXXX in QX still back

for the the week last volume XX,XXX time this pop first fact, In over up NRX we the saw since COVID lockdown.

better an So that's to days think encouraging sign and I points something that ahead.

when back acne kids to the with so it's patients, by school. driven go typically seasonality, Regarding

see the by to warmer from of patient over a we weather the and true these driven course of August component And July specifically little in this different. the volume There the in April see that do year. diagnosed we change With seasonality cold some So it's March, spike and is in the May. typically seasons triggers have, volume weather. patients a rosacea,

And slightly so that treatment. should higher rosacea seeking a actually of be patients period where are time

also search We in volumes. that see

but they're and So they're what patients the just not see triggers diagnosed, rosacea. for related are phenomenon, searching searching we to for getting with same that when

our there with to strategic aligned true So component disease is thinking. that that something a seasonality and is

Operator

it this like would further time, additional questions turn at are management to for no there I back any or to As closing remarks.

David Domzalski

on to We'll out there. schedules a out to and wish soon. safe Yes. continuing you. of We join their us Thanks, taking provide for forward look have operator, we to this everyone thank everybody to rest great on and healthy of progress, Thank the week and our to time you and an call. stay update speak

Operator

And participation. will today’s you thank your conclude call. for that We

Foamix Pharmaceuticals (FOMX) 7 Nov 202020 Q3 Earnings call transcript