Clarus Therapeutics (CRXTQ) 19 Nov 212021 Q3 Earnings call transcript

Hello, thank you for joining the Clarus’ Third Quarter 2021 Financial Results Conference Call. Today’s call is being recorded and webcast live on the company’s website at www.clarustherapeutics.com in the Investor Relations section, and will be available for replay for 10 days following this live call. Please note that discussions today may include forward-looking statements.

Forward-looking statements involve a number of risks and uncertainties.

Some of which are beyond Clarus’ control or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. described Securities include, the and not with pharmaceutical the position, those prospectus XXXX, filings the SEC, uncertainties October risks that to, Clarus’ and Risk with Clarus’ and XX-Q. future are included the Exchange under filed with heading association and Commission, development, including XXX(b)(X) factors risks but the Rule limited are with the on financial Factors of SEC, These the in the those under risks X, in association any may These of events forward-looking update disclaims or the the – statements speaks be reflect only as such to circumstances or as any required this of date of by these obligation to expect date Clarus law. call statements after forward-looking and statements intent except

remarks, Clarus. will time, may to Dr. questions. At prepared to the Chief the and Sir, of President your Clarus Executive call this turn take Officer you Bob over like I’d Following begin. Dudley,

Frank and Ric Thank Clarus. our traded we company. in want Thank is publicly Clarus’ a good milestone you. say being to evening history exciting joining Good Financial you your Chief us And for today very Chief everyone. afternoon line that Officer, our on also a publicly is Officer, appreciate Commercial our me today With Steven Bourne. the for in interest Officer, is Jaeger; Administrative Peterson; Chief I

the transaction develop for publicly Water therapies started get a androgen women. the Blue some We recent between me and metabolic with closed Clarus from men and Let to debuted Therapeutics highlights and company traded as and business.

Global currently trading and of ticker. was XXXX day we Our CRXT traded NASDAQ on the the XX, under first September

will all success. to bring involved this and patents they JATENZO listed business to thank U.S. Orange of a the the JATENZO highlights, This Book Trademark to proud to received upon transaction want be make for I total will listed Office in of transaction. Other of seven. very Orange notices patents, allowance the which And the Book. number accomplished covering Patent in put work we protecting from two everyone issuance up this have of We’re

into technology develop exclusive conditions University, Medical treat McGill with CoQXX associated ranked commercialize to and Doctoral ubiquinone with Additionally, worldwide license an to university Canadians deficiencies. we entered agreement top or

also principally flipping developing in as the agreement HavaH principally in an common well. into We entered breast by with inflammatory an cancer breast exclusive disease, form also Therapeutics, and biopharmaceutical men therapies license women Australia-based for androgen company, of a also women

against as quarter third It for payments a Next, outstanding we that prescription year-over-year. claims XXX% sequentially experienced increase Lipocine. and of finally, settlement. – of with patent we XXXX all excuse XX% with me, a announced Clarus to with JATENZO in the and total growth comprehensive litigation resolved settlement Clarus of part of And the

podium turn For the highlights. Peterson, highlights, those the Ric I brief Chief to discuss now our over to financial will Financial Officer,

you, Thank Bob.

of approximately about Over expenses of three and primarily the ended product and external we run. for share decrease of XX.X%, sales This diluted $X.X administrative marketing for a approximately of the for This quarter $X.XX by timing that projects comparable last XXXX expenses the XX% minutes. Net approximately year. with $X.X million. detail XXXX expenses, attributable end. primarily McGill. follows. position. approximately fees of XX.X% for approximately those and at for agency this agreements loss year. We million approximately were as Sales in consultants a outstanding, $X.X to an weighted talking common and of million represents share will net third year-over-year year-over-year to quarter per decrease XX%, were the quarters to due increase corporate nine fees. represents compared license marketing million This year-over-year average XX.X%, XXXX. General such increase represents of of million brand by of driven represents the media net Revenue a were quarter. Total decrease and financial quarter signed per agreements September were approximately both XX, common few Both were results both more R&D in approximately comparable XXXX. year-over-year buys JATENZO margins cash profit approximately license the and million, compared were of costs, as Frank shares R&D Gross and $X.X services be a to the growth a expenses. in the million and in and fees $XX million of September R&D expenses income increase to paid attributable $X.X ending other are sales cash $X.X growth as of a were in net we – months September revenue efforts. third-parties And calculating marketing license equivalents in $X.X or a were our our general basic loss for personnel loss, a and and offset JATENZO the to HavaH consulting months of

this over to So to that’s I’ll the turn the Frank cover financial highlights. it point, highlights. JATENZO At brand

give and public level commercial Thank you, It Ric, to pleasure is be Bob. a you, here to overview. a the thank today high

as jump exciting notable just in JATENZO has experienced time right milestones continues has brand several in. quarter third the an to let’s for the been This So Clarus. grow.

you timing we give associated clarity continue performance, pandemic the me and some challenges COVID let First, that the on face. to despite

JATENZO see increased as continue was steadily have We gaining throughout prescriptions that the year. momentum to

we’ve which success our with and educate regarding to from live business, that continue, calls received of patients experiences rep feedback healthcare all and increased sales to across Our trend able provider our sales a JATENZO been increased to program. payer prescriber has offices success when access that More channels to reach assistance returning possible. prescription finally, of team with the And offices, prescriber continued targeted expect JATENZO. patients positive growth to things, reach co-pay being and driven we overall virtually and prescribers by several aren’t continued coverage by expanded providers, healthcare our is their frequency

individualized ability the upcoming a Medicine a congresses not targeted the to the have meeting increase this for and individualized is testosterone continued October can and data in that reach medical this world achieve with a we at showcase provider to achieve. in providers. patient response is levels the that current by ultimately reviewed XX common I patient to covered on number Society result into medical as of dosing we real because flexibility therapy. our customize which is healthcare to a order trying increasing that important to our to publication is peer provider, that replacement positioned with each testosterone we providers as dose ability healthcare We we JATENZO force better at patient. believe adjusted other coming associated ourselves submitting am treatment issue in adherence, sales the value to symptoms in very to consistent JATENZO healthcare We the for XX, continue anticipate is for journal market On with know, Sexual America important finally, months. expand abstract targeted that the data therapeutic growth This abstract medical hypogonadal So manage have And the pleased presented data, to representatives reach this practice experience and presented month. in may past be an North data showcase satisfaction to the of to second,

summary, we and So accelerated for poised in believe is JATENZO continued growth.

prescriptions X replacement million As it is large written with in about testosterone we know grow approximately market each year-over-year. And year. to therapy that this market the continues

X% over achieved despite in market okay. COVID, growth the XXXX, over fact, In XXXX

treatment. We that This a stop been prescriptions patients where there three the an out because their have are who also administration diagnosed our number know considering currently million written overcomes treated every patients issues an that gels not four with additional patients about X.X to the collectively roughly satisfied the with represent non-oral current are opportunity who large majority injections being oral as of X therapy. with either and is are are million significant a These patients of or today. the JATENZO associated a

In are learning of all such as fact, JATENZO. oral, patients in interested about XX% an

resources XXXX, of providers promotional they invest expanding healthcare move forward targeted the continue educate we As to additional their through sales serve use by that and into strategic we patients programs to and intend force. to

So on the updates at provide this for point, pipeline I will will turn it Bob? some over Bob to Clarus. who

Thank you, Frank.

being a and be to hear the opportunities brought mastitis, conditions $XXX for product, many pelletized delivery. for conditions know size breast a form year, And you opportunity positive, FDA from excuse worldwide adjunctive deficiencies. in From in to as we and this HavaH a Roughly will commercialize the other have subcutaneous of receptor certain to this second in Australian we potentially exist testosterone density treat CoQXX to As and of for mastitis as roughly the for technology product HavaH, therapy. database. year, periductal testosterone this forms this announced applied status cancer. U.S. of breast from inflammatory on and we our May months. University, for from XX% women even X,XXX into McGill periductal this from million. in of cancers been Therefore, product breast Australia has to we efficacy well of breast greater public in of early breast cancer. X September believe into orphan sales back good our believe There estrogen earlier specifically me, Anastrozole than target data, treat and has PK breasts, we’ve with of coming in-license anastrozole, HavaH’s disease positive androgen plus combination the number a periductal opportunity XXX,XXX women receptor – adjunctive a for our we treatment an to where had inflammatory with associated market and of are therapy rights a a high the product drug in of This not therapy combination over as announcement associations could of company, and the currently move CLAR-XXX in recently there all in expect this safety mastitis. there product over – about peak develop this ability studies women used Phase plus In support licensed has

the CoQXX uptake name counter over technology Ubiquinone. The is see unique, to CoQXX enables other intracellular unlike derivatives. CoQXX because is for it The

real of would So an under this secondary Ubiquinone also potential these primary deficiency status. fall or drug treat and in and categories with individuals CoQXX to orphan a think has both we this likely some

several very So which bear in to two, tap work lifecycle believe se, fruit continue generally. exciting us that we all into expansion will JATENZO and on per we androgens endocrinology marketplace. Relative in our management expertise in label products for to products, the

a be view. ultimately hypogonadal is the of chronic kidney men disease. would expansion treatment in the label our First in This

Next would working phase And daily be this then expeditiously move work into finally, we testing. initiated are next on hope to on product. to work oral We’ve you and once a early in a for therapy already testosterone a to in the expansion year anticipated transgender Phase updates female view to highlights individual. our pivot first in that year. a half female be and This for X With few JATENZO. with I’ll a another study just next IP label initiation would clinical of

million the we mentioned where that of only the JATENZO. with resulted patents. actions of at agreed installments talk you against earlier $X turn listed a settlement, were the earlier, recently of action approved then million million but same that Lipocine about questions. I conferences with global in Orange allowance total and infringe, for already. for time. noted it $X.X settlement made in to not from Once also over I Ric, interference pay As a that to settled the that the which – prevailed also bring Lipocine JATENZO From settlement any Book dealt investor to like having global received and $X these been notices two patents in number Clarus our assertions, will us perspective, the patent active I’ll we announced to

Rob. Thanks,

Cantor on for and really XXXX So Conference story Life the inviting Oppenheimer attend MedTech and able also Sciences here us Global those September attended September Oppenheimer to Fall at JATENZO about nine to the Healthcare and and we’re months appreciate Summit the the Cantor were to going tell ended Virtual exciting and we we And able have company. Healthcare XXth, in things both our the conferences. XXth, we

for So operator with over the questions. turn that, the we’ll to call

Thank begin with Cantor. will Chen with Louise you. We [Operator Instructions]

Your line is open.

for in afternoon, this everyone. your actually Good on Hi. This Carvey progress is Louise. Congrats quarter.

questions. couple a expected have of JATENZO year. market next the On exclusivity to We is expire

So to just you as wanted getting to are efforts your closer are that know how you guys date. differently strategizing commercial

your plan starting and so of to three to be guys world. Thank working a JATENZO you will Secondly, you those get the on on big be ex-U.S. just it want regions sense of going much. opportunities. How how

don’t why take Frank, you question? that

the Thank you, cover of I’ll part Bob. that question. first

of we regulatory that individualize as forward the that year our JATENZO which oral, We as at exclusivity towards like expires So believe physicians an the yes, March continue for. XXXX, know, to know patients we need, that and the and date, patients. we the next their in ability look physicians end to looking what is that to are we dosing have

as to the around having physicians we be are continue importance to and we prepare So, the that prepared timeframe, patients able educate for individualized to of definitely dosing.

and talking the the hypogonadism the believe ability out forward. will end about something as also the in the because of of they’re certainly But therapy, therapy. the competitor look, out about at another there on helps of oral our radar general importance having of talk coming benefits importance that that’s So market treating the of day, I to say oral that’s we

So, product. a have believe, we we good

believe when also that the any We we’ll introduction competitor. be continue business that really come strong in to our of position the grow beyond April to comes, a new time

Great.

like to you talk X-U.S. or me do would to? you Ric, want

Yes.

I’m on anticipating, X-U.S. and to been those take speaking that happy as Frank think comments expecting the opportunities. I worthwhile Bob, that for it’s to thanks we’ve which in competition, the So, for prepare we been JATENZO

to rights worldwide have We JATENZO.

regions in we puts have those So think had partners. favorable number a of we out as seek partners with very of a X-U.S. are us partners And have to where a reached and I that number in dialogue there position

expand are And I a deal, for really revenue, at or a And or region country so, worldwide. having. forecast important only that those are currently JATENZO of wouldn’t not we look to an reach non-dilutive particular is discussions any timing on but but that active the piece,

much. Got it. so Perfect. Thank you

you. Thank

from Fraser question line Truist of next comes the Securities. The Greg Our open. is with line

folks. afternoon good and Thanks

patients profile would are additional helpful? what resonating would most the First of the Is JATENZO, JATENZO’s achieved T delivery? with normal who elements it it color Any on prescribers? Is of you levels? percentage say be oral high

take Sure. Greg, I’ll that.

are question a that say lot of our there’s components about profile. baked would a that, that So great into I Greg.

of kind dive in. So let me, right

any product, really administration. down the have right. efficacy, then dosing. is the that obviously they it But why the day, a At a prescribe the issues oral, route to end First safety they ability to of an the goes of and like back key reason physician,

circulating not on our is and we patients but to for that at a any hematocrit that XX% So the the impactful. the their stayed we’ve trials, although talk have started not in gels, that’s where profile go key the therapy, But patient them, clinical to data the see free donate their importantly, safety. when gold actually are only clinical their from seen target do come normal as us they they we blood, context increase resonating about all efficacy, to majority safety by physicians better more do of increase will they fact, ability In with of take to they on view Contrast where a our bloodstream. that single a come have to patients in in of They or that against toxicity work we understand able is what look the the with injections, dose. really actively who off, hematocrit decrease see prescriptions they with sites. at all would stop message testosterone they our in it and that one XX% specifically very the study, as write those XX% physicians break, of about is standard whether not liked see of in hematocrit did injections, any perspective, of manage And discontinued. range injections our is relates that our have as they’ve unbound actually where a amount to and and they of we way, liver

other So therapeutic patient very already customized as is the depending have that well. as that’s the as we response. target what and for ability this have to And is level looking doctor is that dose a the the is impactful as very earlier, go the thing well mentioned the I impactful fact on individual

kinds combination those differentiate of in of providers. all So that the are healthcare really things with our JATENZO

day Is a hurdle once into a you twice a think big daily will for difference. dosing, a go some, to and make

hear your on just once population. versus for to twice I’m patient So curious daily thoughts dosing this

we’ve reality the You this get really When not know patients, to When more weird, which have lot, follow-up it’s an great to would that a the know day. question back, that twice in really is heard a from perspective. talked from comes we so that get the haven’t up or day is don’t physician’s has a data feel period, day. then the I with But hour normal something a patients take that over that know to. with a and getting the they’re heard been we twice like And that we’re to morning a must we a be by I I somehow I as patient a you there low, issue a Certainly be day to later. well. taking see actually in twice as is that testosterone more so XX range some and take testosterone is get really we, perspective once

range normal difficult, range that’s I I staying there course very high, the a but over the and of the because too there be to unicorn because normal see. we’ll in and able stay importance of think, think day of not those, going the to it’s out that it’s into of one get

with a as then well high coverage on improve to coverage, just of the that new you coverage as is expanding That’s payers, it. working have? already helpful. priority Got And very

Right.

So plans have happy JATENZO. have all those say of in we that lives to coverage the that very States XX% currently about coverage, United

that lot very course of the made year. a over we’ve good the So of progress

I to plans plans other from a availability exchange As beyond, still forward look have D, lives. commercial as next that to a we the health states, well Part year are back there and from Medicare to go additional perspective, into as

priorities. to something remains certainly is our forefront that continuing of So grow the at coverage

Got the questions. it. Thanks very for much taking

bet. You

Thank you.

from question the comes & Company. next with of Our Belanger Serge Needham line

Your line is open.

me. for afternoon. Couple Hi, questions of good

talk mostly or And do The first just diagnosed about settle they you Are Ric, I the can to nets? coming one newly from moving where you gross and patients around, are switching existing they talk maybe when? still you for from? Frank, just are JATENZO where for about they’ll guess secondly current products? You think Thanks. to be seem can

Sure.

the pass it I’ll first So Ric. then question I’ll you, to handle over

patient where all far from? a be would all on see the you the is so prescriptions are look of see who about the as up other is new broken So you’ll and patients of As percent of about or are coming JATENZO that or as currently, prescriptions continuing We are Those so the patients. follows, X% was other are that if patients switched XX% from the that previous what XX% at XX month. to market. our

way the to patients data basically on market, little new perspective. XX% time who coming that X.X. XX are patients that sources. defined so break least the first out the JATENZO, from and Serge. more XX% not in switch you if And at that are is the It’s coming So that the the that bit Is a of anybody a help from are for balance, overdose who’s or the

helpful. very Yes,

Okay. Super.

close. we second very gross to to on the And net, Hey, gross Serge. Ric. It’s question the monitor continue nets to on

through As have more running increase, script going we’re plans. levels to prescription

copay we on card are We’re have watch that assistance and going those more historically closely. estimates of to our have very going and made continue to those all through prescriptions

a So, XX% earlier we get to adjustment so had XX% projected net, net sales. to

last XX%, I trend to it to it’s favorable to but but for quarter you watch seeing quarter, continue and increase. it are guidance trend been want we again the over third year-to-date. that a don’t we We are number We favorably, as to that favorable trending today. in Historically the will this scripts have XX%. carefully think

Okay. That’s helpful.

you additional in expires? more, me question crystal about how look Let March. to follow-up expect in many one squeeze you ending your a I’ll new in a prior market entrance the to ask after exclusivity do exclusivity the ball,

Bob. about expect is This I one, care another?

Okay.

will Our Naz Instructions] Thank with last Maxim Group. you. come from [Operator Rahman questions

line Your is open.

on the congrats quarter. guys, Hey

a questions from Just few me.

disorders been start odds. it First also. odds on prior to for remained odds of the decrease rates the I’m like Have seen same going guys approved? physicians prior prior you all like get to easier the increase, Has

Okay.

will questions. deliver those. So thanks those for I

So rate actually PAs decrease first, to the as move as, continue of to continue we forward.

year, important getting that be over what has though, the exists PA to class the there to obviously patients replacement are that our space. is a distinguish say and expanded As that more and course the I fair, PA coverage more therapy just though will that, is who your that testosterone of question in it’s covered. exists the anybody for

a that of you now and So all getting seen have approved around, two would the injection, generic JATENZO, the class I XX% last you about those specific say TRXs through. what data gel, do that branded we’ve period that then are of are questions a out and male? are is and Levels? as you T Those you to came Are had overall. a all look, are actually the related generic are going if – competitor a

that our your certainly we’re represents that through. those seeing that’s a to, of going answer a question, kind more So improved, coverage prescriptions strong payer has as of correlation Does Naz?

does. It Yes.

next question there quarter? stocking sales just for is on the any significant or quarter, any wholesalers by of significant stocking the for the So the channel my was

Ric. not. Naz, was this is There

logistics then through wholesalers order them. third a provider the to party So our sales go and

take So do wholesalers, have but wholesaler from we orders directly the don’t we data.

hand, wholesalers large course, no there that. to and, So anything remained date, days like on stocking orders consistent as was no, of

that in something not it’s we So manage the we manner. or from orders wholesalers take

sort just you priorities increasing how like my asset? your sort versus DTC perspective, increasing you on could of, Got is of capital if your of HavaH sort spend it. rank development on on And or would your forward, CoQXX spend final your from the going question

we off. JATENZO start can and our market JATENZO on watch I’ll and that, we’re prioritize Bob been carefully in, leader. has very Yes, And and jump as making then we Frank certainly focused

or at so a on it And when those of funding look priority programs, continue as are HavaH DTC And types spend maybe things to buys, certainly those you we on program, to the programs. those be those whether media for or we’ll spend us. have their

remains I that highest the think is business. priority growing that

our to Secondly, R&D programs us they’re I really think are where favorable structured very based. milestone

So success in those build programs, value as associated payments with we milestone will we and achieve those. make

very they’re programs, would that So standpoint, say think expensive large I hugely programs. they’re structured on that favorably not R&D from also these I

very think I those without programs. we go into dollars significant can those huge manage effectively

Alright, thanks guys. my question, for taking

bet. You

you. Thank

I over Instructions] turn to now you Thank Dudley, Dr. would call to remarks. back you. for like [Operator closing the

appreciate Thank on you. everyone I taking time the be call to today. conference

one public first the is company. Our

into very going, our commit do, continue to and pharmaceutical about are where to a certainly and very we’re where grow excited utmost profitable Clarus we to We’re company.

will So again, after you conclude operators our call upcoming best remarks. And holiday. our thanks, wishes this the the for Thanksgiving then give

this Thank you, conference call. ladies gentlemen, today’s and concludes

disconnect. a You have day. may wonderful now Everyone