Agile Therapeutics (AGXRW) 9 Nov 232023 Q3 Earnings call transcript

Good morning and welcome to the Agile Therapeutics Third Quarter 2023 Financial Results Conference Call. Please note, today's event is being recorded.

I would now like to turn the conference over to Matt Riley, Head of Investor Relations.

Thank you, operator, and welcome to everyone joining us on today's call. With me today are Al Altomari, Chair and Chief Executive Officer; and Scott Coiante, Chief Financial Officer.

Amy of also today's Officer, the available Commercial portion Q&A call. Chief Welsh, be will for Our

Our prepared outlook remarks on for current today future. will include including the concerning forward-looking statements our financial and prospects expectations, financing statements based

strategy, with relationship and and and telemedicine and ability of Our the to management's quarter expenses, Twirla, plans, and our performance, our expectations its expectations. quarter regarding expectations business financial XXXX, including future broadly operating among first our patients, growth, to prospects ability to combined outlook generally, Twirla our our our our providers the fourth make Afaxys statements market promote for operational their of the regarding other and partnership XXXX hormonal available contraceptive with for assessment market our growth

our statements. Such that and risks of from the in as may not results results differ today, uncertainties and guarantees promises to judgments discussed statements forward-looking represent or involve may actual cause are the

we certain issued today, Further, non-GAAP on in website. release press today's of of non-GAAP our section measures can is refer be to Relations reconciliation A call, the which found GAAP during our measures. included financial will Investor to

risk to factors Investor SEC, information affect more please of may our refer section Relations For concerning are available company, our the the with the filings that which through website.

and The We undertake purposes no for on sufficient today's information as law. is obligation statements, call intended by forward-looking to promotional not update prescribing required not for except decisions.

that, to with Al. And turn the I'll over call

quarter once achieved several including factory you, the gross Twirla the for net call sales, across morning. taking time we leading Matt, to to again third our Thank revenue, and this everyone highs margin. indicators, demand, Great. join In and all-time you thank XXXX,

announcing and product, our combination revenue we're XXXX The we Twirla, million. continued we the first achieve quarter positive cash operations of will strength confidence with expect single our of from XXXX. that flow And generate goal at net today, execution that $XX to increasing momentum least us and gives in of

to It's year quarter-over-quarter our that been In improvements X of maximize total approximately is since XXXX. operating plan the believe consistent into as of across while well we the OpEx past managing for areas, seen recalibrated there growth in room expenses performance both or the levels. our emphasize partnerships our fourth business we've year, we first and additional growth of XXXX all key quarter as quarter simultaneously

XXXX our get in quarter flow cash in from into revenue quarter positive of of first performance the generating confidence our and now I'll the operations supports XXXX details XXXX. achieving some our of third net that goal

revenue. Net

Third quarter in quarter XXXX, for third XXXX. second revenue XXXX new Twirla continued to net quarter Twirla revenue once and of XX,XXX increase XX% both the net from increase was XX% $X.X non-retail a cycles, driven quarter record. channels. retail by across The our million, demand ability the primarily which up demand again accelerate was was XXXX, quarter represents increase single a second total the the of from

quarter increase a Symphony record. the the increase also a XX% quarter of Non-retail second as XXXX, reported was single XX,XXX demand, was by cycles, of XX% a quarter cycles, Retail total XXXX. demand XX,XXX total second from from

both non-retail from comprised wholesalers. As data is well as reminder, Symphony as our demand a of our

of were of XXXX, by from the reported total quarter the second XXXX. in was XX% cycles, for sales XX,XXX that increase wholesalers, a quarter Factory third as XX,XXX reported the our cycles

become sales of with meaningful profit, a continue which our progress in and Along from story as cash flow has generating part our to our growth margin. Gross we make of more goal towards we our operations. approach gross demand, positive

of margin of gross $X.X or generated of XX% quarter margin the we or to million XXXX, of compared a in quarter of $X.X second third the XX% profit gross In gross million XXXX.

level OpEx improvement remains the our both the As our forward. expect quarter moving net see margin million are third we gross OpEx steady, increase focused the from $X.X X% XXXX. XXXX quarter as to for on second gross reported of continued of profit increasing we $X.X a levels million, decrease for and revenue and were

old approximately and states of call, that are to to XX estimated profiles additional Twirla -- the XX recalibration our can X in distribution I and expanding Early reimbursement who to on alluded platform growth The Twirla commercial women, X fixed we drive following: partners, XX% scalable channels. believe recalibrating business the key costs adding collaborating our a focused recalibration ago. reach have strong by year with by the our approximately plan the the building without driving in years

X the our XXX%; delivered OpEx of first growth, of has versus recalibrated revenue the business first months Twirla Compared XXXX XXXX, plan XXX%; net reduction growth; following: demand X the XX%. to months of

and and growth growth our and is the expect sustainable, coming into from growth see We our that has The the plan Twirla that to we date see quarter upside delivered following in both affirms additional model XXXX. our belief continued areas. potential fourth to

further as First, our focusing in increased room key current nonwriters converting on prescriber well growth into Twirla. there as believe through for in We base of is X the penetration penetration states. these states

Second, Afaxys from network. the additional volume customer

customer XXXX than to non-retail forward. tap an and into quarter currently are total we XX% additional we third the less of estimate reaching grew Afaxys we to the plan quarter non-retail impressive While network the XX% demand volumes that second from XXXX, moving of

retail and all sustain through Twirla our such of to Nurx, profitable Health strategy Pandia, telemedicine the advancing channel. in part Third, our platforms most growth Twentyeight channel, as

progress also which Before the we financial on a demonstrate we Q&A, open fiscal comment believe business will Scott discipline. results, and continued for our other few

of our you of the encourage quarter and financial results the XX-Q for read third for review Form our press to statement a XXXX. also broader We

I'll turn it to over Scott.

the a or $X.X goods margin of of a Al. indirect of in third direct XXXX sold, resulting of Twirla XXXX. of of sold compared XX% to million second $X.X for to the the margin Thanks, of were manufacturing gross quarter Cost which and costs million, gross related XX% consists quarter for

quarter the $X.X of XXXX We million. of third cash with ended

In addition the available will to continue at-the-market ATM or options all arrangement, to company. to our existing we finance evaluate

million the of was compared or for and per loss $X.XX to of third quarter for net the share XXXX. Non-GAAP comparable loss $X.X Our GAAP share quarter $X.X $X.XX loss $XX.X or the for to non-GAAP of GAAP or $X.X was period net the of in a a for period compared million share and in XXXX. GAAP $X.X share net $X.XX per net per per or million million second for $XX.XX for of a third loss second share comparable $X.X XXXX $X.XX the per XXXX of quarter per quarter XXXX loss or XXXX million or million net $X.XX share the

transfer value the of which XXXX. third $X.X reflect XXXX market The equipment remeasurement XXXX. company reflected of XXXX warrant ownership fair quarter is second the in and the in $X.X the quarter quarter results the Corium, which non-GAAP of of $XX.X of $XX.X incurred resulted million loss third to a onetime the other noncash of XXXX, income of The operating of to net quarter for exclusion third expense the million quarter in related in charge the the of in of liabilities million third million in

quarterly net revenue the We single This cash goal, our our expenses. articulate highs in excited now momentum another continues decrease company, achieving believe quarter for growth where we results Agile, are positive first generating net factory in and from the and in operations while taking set our reporting once are quarterly to of XXXX delivering revenue XXXX. flow again XXXX continued we in record operating demand, but all sales, quarter

margin, continued our on that the flow from believe of our help having gross and about discipline focus to us continued We cash. to can turn us fiscal position options revenue can operations how put to to positive begin which lead in improvement and generate invest future in growth in cash

line you We'd now to open give to for ask now Operator, questions. the analysts Q&A. our opportunity may like the covering

[Operator Instructions]

Wainwright. from Livnat with H.C. It's Oren

Congrats Twirla. sales I I outlook at project point have have I'm follow-ups, rate rate forward? and to the breakeven. needing quarterly guess you million OpEx current, the sales breakeven? I this annual I'm please. us just that your And you or asking appreciate I XXXX gave you see curious several margin on year and or where continued is minimum QX profile run exit highlighting from do going do in the $XX refined a what specifically growth few.

Yes.

So Al. Oren, it's

thanks of all, Yes. for First joining us.

momentum I improve. continued also in nominal comments seeing in think continued that the as you topline, percent, a see growth And would a would as expect, X that, the on We're his right? point mentioned but then margin continue dollars, right, real we're hitting things, so right, right, this with dollars, right? business, Scott leverage, improvement to we of both on

in path in affects will growth will, when the a we that project cross, think will. so we're margin if quarter, -- and we that So those you if on glide as out the topline, you first lines pave it improvement, percent

are on I we've yin kind So the of or improvement last it's yang but always tried is in because a a year that so. bit little educate the margin to growth best Street think for also your friends, The topline of

of are to Some the we fixed cost. margin take charges the

of we as hit points So just grow, we leverage.

our sales So path the quarter demand what's also basically, the it this... fair. expenses first line both for we ability and see okay, to That's but an saying, crossing on to glide in margin, manage in the when we fixed and OpEx effective what's look the forward in on

Okay.

think of business? Or scripts rest the retail you to you hopefully, year think straight-line least obviously, to goes, guess as from? there into track. a a that this in can in at do X-state I and mean, where IQVIA I to the we of next business? growth of seen continuing sort add as has as the come and as your through Is far contributions grower job. the Afaxys think do do great should about accelerate she sense. as on new Makes strategy of Retail steady biggest lines of, the I other been year, are going anything we continued we've sort that view,

Yes. see some but all We're retail the excited more spillover Amy, think I'll retail, about it that. queue you the information with I'm she'll share between non-retail to the synergies. to me Amy's call the gets what and going I is got and about up starting

And in our me gets is retail So the also that's other excited telemedicine. specifically where it thing that the helps channels, the non-retail business, effect, business. accelerate

we that only Madison. Thirty you channel know, is rely literally surface Nurx This acquired on scratching believe we're a by was as I And partners. there. the

went period of we acquisition through time. So an

stride to So there. we're just starting hit our

market I channel in more the to of layer then So forward, the We ACI And but overdo the non-retail synergy mean, I on alluded not fixed. deeper a X this, at the I line we're and the but but and look topline. when acceleration specialty pharma states, try to on share turning on as look, of that we our both that will we the business comments, Oren, the at around. believe we also margin that goal get just think believe the of adds my

excited. don't So comment. that's gets you want to know, me Amy, if what I

mean in why I we said. -- you to in spillover grow that in I more add see tough and Yes. just time the in I'll about measuring The context large That point. to reason non-retail. made that, alone well account had was Al's some maybe we that QX add very for one area here. state It's helped a another to saw X is XX%. believe we frame the that

prescribing strategically So been Twirla it. I and to be improve bridge that the be offices, to continues to with it wanted confidence perhaps think they where retail non-retail haven't we

accounts been even So doing reach place better as who broader partnering job 'XX. and true a to maybe are that have good some having looking year. add stabilized of this bit and forward. in more spillover We're they've moving good even and like we to we And systems a have in Nurx, that a partners now we continue our forward seeing

that constantly So you improve. couple looking at to ways We're and that's just other -- things of about. the know

So optimizing the me, about really, for that it's have. we partners

them, have begun to well better. do We with know I do so just we can

Amy. Thanks,

think, I where improving for happens, year Washington it is on line ACA -- front? but a really past Okay. we'll on in you it's in like If you not mentioned the that there the is confident see goal you Washington. change what on I there, your from something expectations of a change Do are seems see Is tone And on Europe. thought calls tone, there? may,

days, being mean, without there do mean, the answer the too it's country. is. ignore I of Yes. I look, to couple this political? How hard on in I last right,

I of everywhere right? think reproductive this country, in rights mind are on top

ACA-like and a who and So people of What's we happen we win looking these for in lot brands in in the They myself, just into of Washington, of was women that put unfortunately, this very states got in this color. and things coverage Jersey, I to live up to it's gets so mandate direct that place to also, the interesting New interesting of telling, But including country leaning hit a see has the really believe, hurt folks and this by with women this is women because women do hardest the see worse I denying there's to up. we rights. in broaden actually reports country, lobbying, decisions a put of say, the congressional the stepping this time study for that stop. franchising get one one to are reproductive and this is, that, working, state in or should make

if is a into this. principle but say work will, the I'm line. the in -- we've to It's proud between competitors, space, just drumbeat, all think we're is this think, the I unifying So and all all know, you I leaning done, you on as the our goal

use bit feel as yes, already. just bullish, We'll goal a So getting line an of and get this not I excuse the little but would that on And is it. brand to not commitment what morning that a we gasoline is goal line. to to made this The the a hope you without throws a hot we Street after, we for more

[Operator Instructions]

line Maxim with from the of Comes Rahman Group. Naz

regarding an since over what on few. summer. executive the by additional they Congrats FAQs lines Tri-Department is Can Do see the time touch believe contraceptive look potentially made additional I have Twirla is updates on FAQs on reimbursement. the order ]. point may issuing progress issued any [ or when responsible you any potential like? Tri-Department's we for present I have and you on a

the the alluding our at X Act Services, insurance excellent to to or Treasury Labor. is the Human it reeducate mean the question. Affordable It's just Tri-Departments. industry I in Yes, everybody, really departments Naz and/or regulate that government believe and Care not,

goes and Human can I to quarterback since the use primary in season, of has probably of if as is think the issuing the the our you tri-agencies, human So guidelines. back and quarterback. systems. responsibility services, the days it football But Services unionized them health Health

the be These this Senate to issued of and doesn't into So our have guidance, the unlike when see to or we need what's if to go in to by that Congress going on guidelines the to Human country, Health debated. you clarify are floor put will. be Services and really

spirit Affordable or formulary, which direct a physicians what of letters onerous necessity, go least in on is this a if actually in wasn't had drug medical this in of executive Care weren't to order. Affordable we said -- if excited Biden the prior that physician Biden that on What as you the know, is on authorization What through in the order the executive said Act, us Act, violation be. or at formula gets Care

the make saying, make work suggested this better, just to believes let's system and Biden Congress easy. right the So

approved own you an cost than in when better. the get to formulary. exclusivity, formulary drug whether different have a off that all effect, that you're you the to it's your plan just sharing other no on equivalent, formulary, have And leave They're for decisions. work makes you system doesn't If your then decide contraception, generic

floor see the services. by to debate, committees adopted the house bullish the what gets waiting recommended it have go We're oversight And get now the either it had doesn't for. to it waiting we're human for of I'm what that's So guidelines. Congress that reason and into to helping

watch to and all. balance, for in hopeful right -- PBMs we we're adopt after insurance to these that see so and the we've waiting that in once the companies comply, then And this the involved they'll fair now. guidelines getting their And President time, got be hope this, we're that's

So Health this, is we attention. a Human lot getting of about and believe lot Services of inquiries a

was then He a in he of OB/GYN. where and laws certainly aware married he's put part, Becerra's The the these Secretary interesting he in lot of as of you know, this. California, -- was place

issue at to going on help is through. a So little what hopefully, OB/GYN home he's going this of

and And do to, your to let's in based call sense contacts on of done guess, we're greater half of urgency cycle been election there's administration like get point, you've to because a everyone the 'XX risk first mitigate the I that entering on just it, think speaking this change? you an like,

Yes.

I cycle. something the our easier doing team think and I to that it's personally, over is going Now believe it This And a I yes, election I want of table. the what of believe. you leave on practical that. believes From ahead management lot of world point a view, don't believe

So urgency sense on seems eve your of kind election. order yes, of house to there be in an getting a of of the

plays yes. Yes, that into it. I So believe

want for take be D.C. mind two space very lot complicated Clearly, time, that's of we that other issue. that the reproductive have first I product over-to-counter Again, abortion There's fair And to mind subject. an and balance. issues a of does how lot now takes a reimbursed, health this space a get down

handle So is all of we happened that issues a with a of that v. out held these of that. of the are that. by believe on think federal with took space lot do? So the we've down lot we're That parallel. Wade. being are Roe D.C. dealt What what mind I because been up can how in to government

Biden and in that's So we the up, we're then evidence to rising sector Reproductive think contraceptive executive to is the coming health top. order.

on commentary versus prescriber Twirla? to prescriber Twirla's of this growth about I is in due prescribers provide much little could script, And a how bit deep this quarter. how think just scripted know you much growth are to growth increasing? performance quite talked the the do And you some Like a date to dig point? you on at but in

I'll Amy it. handle let

Yes. It's question. a great

So we're that. recently, looking at

coming the see XX%, now we're we is naive what coming we're of better. were new patients. to patients. of means month-over-month, or is at seeing We're end XX% understanding Most what is So from scripts. here year. about we're And Twirla new coming starting prescribers. from our that growth the new And the our of Week-over-week,

-- perspective, went on already I From over a little data I put XXX each now, as we retail slides through week. prescribers new the a know but we see the

pretty much good, see we that's more, but weeks Some average. which an is

if I what know me let color So our Naz. already on said, additional I've get community

find consistently new writing those new prescribers you prescribers them and scripts? Yes,

Yes. be coming patient Twirla. And they think their see see we then them they'll You add more them. patients because patch But starting are apparel that's [ than is After first in in confidence as new. good new patch annual me, coming good. that, from talking about switching that a and That's on finding that's They're see us they're patient that may wanting getting Twirla how may business to rather then ] give not to switch. to them or the we to and fill. in their

is So control that to get that new finding corporate is think a form. want what doing physicians patients these contraception are

off prescribers-or-so starting XXX week putting Twirla patient. these new yes, a typically a So female are on naive with

And Got question. it. my last

XQ. any an than that effect Regarding or in the growth the Nurx? is have seems quarter-over-quarter this around idea was It in Or you Do slower just on of and were channel factory is? it it sales kind growth. that comments like why was quarter, retail

mean, to and no, Amy of complicated, were -- we they morning, get doctors this little and a Symphony. I tell reported be don't this with prescribing the don't talking a me. going lot No, bear is time in them I so

we have the know but that bit leave it's to want now, seeing, got little kind steam. of of bigger we right to more a head for than a just you're side growth until So we off

than around I'm health -- But growth. know we're call just Symphony's channel. if better women's look, retail and look reporting disappointed or not with the I'll in sector at be, said, So we pharma. all that double-digit we look you it, doing the off around specialty putting And shouldn't

we're So growth harder are double-digit if a gets bigger I small putting no enough, spillover mentioned, more The us -- see big all that up writers indicators, insights and writers your new to a as the as look, to business leading on I in we in done we asked, little direction. writing say mean But basis be Particularly was seeing question we the are you would is they even not feat. Existing make name our right is yet. you great. quarter-by-quarter mean, we're Amy consistently right? better. heading will, clues number, feel is like clearly,

our on focus we to more. getting writer write base So existing

have We grow to we physicians roughly, to brand ample writing get just more. So big got a this number level. to of

some general, think category. we the resistance Care related in this brands of the Affordable And that In them Act. to is with frustrate frustration

So growth that is helped, help network But that some more. we -- in the specialty excited doing, meantime, with the the Amy will based in Amy that of retail seeing built we're on we're common. analytics of a forms but more guidance it's

was That Congratulations the progress. helpful. Okay. on

We appreciate it.

And back I remarks. final will question-and-answer period. turn this Altomari the it to concludes Al for

Well, thank you, everybody.

a heading are going -- That profitability. you you mountain bit How talked $X.X are to goals concurrently, you kind of And you me That we're get we to said, of steep there?" climb. be having "How truth first as our Sort then we and as $XX-plus the going this of there? reflective much be putting the said ambitious to about this of you first called now, the were was we and year, year. a appeared number showed get million. the the to million which up quarter, When we of will

we we But and was $XX think million. this get were the that $X.X we to posting still quarter in million. seeing, can And second $X.X the we million we're and brand management -- team now so believe level saying in indicators this

do math. could you the So

to and moving us see to forward the We expect see growth first us continue fourth big we the quarter, into quarter, in growth. should expect that to

of to that's forward, excited be the we're just at looking happy So this kind then here moment, thought. and

off do having we we it have we to but okay, do the look I company that even on the we days And more. accrue, the debate company hopefully business this believe this cash cash? but beginning and it business that of with what throwing When X we as grow to happy year, of expect be could to a eve next decision that a is have is an at call opportunities saying, Do be we interesting make to and let we're thought. this we the

Number partners work. one, our

So partnerships? invest our our more and Should more force we force? works the should we Number in sales sales two, do works well.

you showed also what that on we we product. a earlier works say of should need digital have and broader offering. Amy do need We there. we to But strategically, more have X-on-X to

term a business show we're We've to So we'd but eventually to cash, to for you -- can that a ourselves not then throw confidence. in this now, this love debate short with got right and post million, $XX is got have we've we done, our of and degree but a have off bring get high goals. we

help we'll contraceptive have. category that we the with of said, to for women Secretary that us physicians days that look let want business Mike gravy. ACA, question and of the environment, and they have confidence my love without And is as ahead then you we of our With But is this the D.C. with get commitment help this their the me Becerra better Oren's just see help get and them that there

you our there? almost and for you We're we'll So for challenges we you let there, it for thank can again do -- management your thank But your 'XX. for then up your team, team tough of and in Thank may thank about you your and questions, of but you. get support. you Thank support. the saying,

our may for disconnect. And you and thank all you call, now joining