VERU - Earnings call transcript Q4 2017

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Operator

Good morning, ladies and gentlemen, and welcome to Veru Inc’s Investors Conference Call. All participants will be in listen-only mode. [Operator Instructions] After this morning’s discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. The statements made on the conference call that are not historical in nature, are forward-looking statements. the to assessment our reflect and the statements related uncertainties businesses. forward-looking company’s of current risks Such

Our actual statements. obtain risks company sufficient to product results the risks financing differ communications related acceptable press Commission from cause to company the to and results Exchange related ability materially future developments government needed or actual of as in could include developments and the the such such releases, filings. and terms other in competition; the fund to developments development to development and portfolio; forward-looking risks or operations; of related Factors things when shareholder may risks; the Securities results that on contracting and to differ detailed risks materially company’s the company’s

regarding CEO President. For would filings. SEC the over to Steiner, risks, and you Dr. turn conference company ahead. I XX-Q its to the and such Mitchell additional Please Inc’s information go review XX-K now to like urges Veru

Mitchell Steiner

Veru leading clinical and Thank are drug fiscal Steiner, development building for of joining a been Kevin to President the Senior And fourth is financial oncology Veru Vice as biopharmaceutical Development to our Inc. very you, for commercialization and urology me become the a company. Dr. It Mitchell year provide urology our on our Gilbert, year-end our making and and proud of I’m Legal. and XXXX. morning. highlights well-positioned our with will provide to team we Today, fiscal quarter foundation and products, PREBOOST; growth. accomplishments for Corporate as update very now and well Greco, year President, progress Veru we’re company. date of is of has productive pipeline; FCX Vice the transition Finance; and we CEO biopharmaceutical Executive President and operator, Michele This as of a oncology good an

high-reward and regulatory on XXX(b)(X). low-cost, known We as initially pharmaceuticals, near-term, pathway expedited using are focused an

the several same ensure the and drugs near-term Our solid to commercialize a several on of is to have goal near company to have file in time products our at future and trajectory we in urology growth. multiple progressing putting oncology, shots and mid-term that

this We’re goal. on delivering

have a granule medicine BPH as is most prostate, for new We marketed DRS, FLOMAX. known Tamsulosin for also causing currently advanced the release of in formulation name slow under symptoms urination popular the difficulty enlarged and

the will Tamsulosin bioequivalent conducted a actually capsules capsules. swallow study and XR who As to swallow and XX extended of be XX% FDA allow over that we capsules or formulation formulation. urology lead those because men XXXX, capsule it’s primary requirement would or also stated all or final men up care care to cannot Tamsulosin in dizziness. studies, granules the our that release slow into in be meals, XX% capsules. tablets nursing broader The be pressure have is formulation with put can that no to men granule this the agreed NDA us discovered of bioequivalent open, homes of XXXX. compared may the FLOMAX should crushed, be to tablets insert, years difficulty the and in Augusts long-term or that clinically markets, existing population NDA. not slow food does low proprietary plan taken be be target and will as conducted we us to new the granules FLOMAX of age blood A When release – have there for single FLOMAX these it to appears effects to unlike the target will On capsules. can side a in or that including filed general serious release FDA chewed, allow because study required with granule package not We to will bioequivalent XR

the proprietary Tamsulosin Release which granule and Delayed low same purchased formulation. also Solifenacin Granule DRS We DRG, delivery licensed release platform technology formulation, has as our the

milligram a ingredient of urgency, overactive available no formulation single swallowed the XX% multibillion the a treatment acceptable in between overactive is by women. market home age. bladder have XXXX tablets be of a short-term VESIcare, the FDA XXXX. symptoms XXXX, of of There will treat Solifenacin filing. immediate signs overactive the bladder milligrams, difficulty the formulation men bladder products the opportunity. DRS. By and and active the dollar ensure of we NDA of bladder. common November treat the To combination plan target and which [ph] formulation capsule We which cannot offer further would is Finasteride same population and and a increases be shrinks condition of CIALIS, to tech Consequently, the bladder drugs a prostate symptoms with Proscar and BPH bioequivalent active for The with that in of milligrams, the have X proprietary overactive for would States be that capsules who for be to overactive which have and The treatment large study BPH. in in and a prostate agreed states XX% agreed not complete In drug symptoms Human Resources, NDA FDA and the women to in swallow for BPH. channel with to United contains smaller with a us is XXXX, BPH initial in prevalence incontinence, and and in of granule Tadalafil/Finasteride which utilize in for a facilities conduct well. progressing women that enlarged in dysfunction, new and combination with allow and approved family treats purchased to urge the FDA Tamsulosin FLOMAX, erectile place urology men approved November Finasteride Tadalafil/Finasteride insert we of for XX% Where already and ingredients an acceptable nursing XXX(b)(X) combination filing bioequivalent file The residents is Department the bioequivalence prostate. size will long-term mechanisms as conduct who in file who have tablets, initial bioequivalence milligrams the package the long-term-care NDA did is men prostate, X At plan XX% X This control. Tadalafil We In Tadalafil of must licensed symptoms or have XXXX. recent the to a in another men will conducted XXXX both be time, in According same the XXX(b)(X) symptoms study Tadalafil/Finasteride whole. men study will study of and shrinking single that proprietary multiple combination Health a is the study sales BPH have treats to a different Tamsulosin frequency bladder, capsules. formulation, the X is Solifenacin that NDA

treat The is urology the DRG overactive May well-positioned in flashes launch, over are which we treatment capsules advanced to the urology cis-clomiphene of products: men to We citrate X granules, Phase come of allow hormone hot clinical DRS for combination prostate into oncology to agreed dose-finding can FDA next VERU-XXX, multibillion two-and-a-half wave therapy opportunities. capsules; and the years. file, XR cancer. of Tamsulosin Tamsulosin dollar next will us or when on that multiple advance and XXXX, drugs will Solifenacin Tadalafil/Finasteride granules, their bladder from take and partner appropriate pharmaceuticals trial. four In These advantage BPH a

IND the XXXX. initiate Patent expire clinical file was It and Phase noted should will issued VERU-XXX and recently We the U.S. in be in early X XXXX. trial the will that for

in Advisory their review – met VERU-XXX to is December citrate fixed treatment our fixed of VERU-XXX, into the studies. FDA X ratio Committee male of an to XXXX. Based on Finally, Phase clinical ready is for excuse feedback, advance me, clomiphene which combination infertility

metastatic and treatment subunits microtubules. other ovarian, developing a VERU-XXX continue Separate cancers New and VERU-XXX. license will novel programs, to be therapy the in products oral endometrial, anti-tubulin Chemical advanced breast, XXX(b)(X) we for the opportunistic beta-tubulin are Entity both pharmaceutical is finding We new internally that and/or of developing also urology a alpha to the oncology. prostate, of from and called targets in

We’re completing cancer ready and treat patients required XXXX. we’re to preclinical the of by studies the second-half

hormone metastatic X/X have we will cancer have prostate target In hormonal castration-resistant cancer today. women become enzalutamide. failed billion that that who XTANDI, ZYTIGA, clinical will will who clinical the in of dollars metastatic which XXXX. in These clinical which to cancer portion ovarian prostate We and Phase X men a trial, breast annual abiraterone, metastatic or endometrial to with study, resistant cancer, target revenue castration-resistant is means then generating are which have open blockbuster label start therapies in or are the have current initially prostate have failed, with is data several cancers we Phase drugs

In also X is market enters would The years the this and revenue investments into over a of is VERU-XXX for a developed well of as Phase large clinical by chemotherapies, types initial lot relatively accomplished past quite which being an two be modest VERU-XXX billion addition, this that other be X currently therapy We’ve tumor today. given oral intravenously can increase anti-tubulin trials. opportunity would and over year. program treated annual next the

to channel million past for and equity resources cycles. our customers, has public two female due existing XXXX tender normal revenues U.S. public Africa, financing. undertaking produced who more the place procurement we for With a to year paid where XX year, We South a our competition, do is we expected unit brands, our by health XXX the international our the Brazil from for beat this the division leading to global this global to growing governments year a products, XX these commercial debt and year public is condom. is totaling bulk Africa year orders grow this health their and female able per division Company FCX Health and with of This aggressively awarding felt from revenue the past In unit a product We FCX million as both by three Brazil the Female condom units. agencies sector PREBOOST. past We’re distribution. fiscal competition not donor public sector, in ever the business year quantities non-governmental South in be million did the than year the should Company need sector, world’s separate tender now years, or believe Health for Female our our is purchased and protect and activities market. global in without the of largest and revenue award this part this with better FCX impact

of infections, both sexual positioned female tenders in from of We’re unwanted early pregnancies as confident only prevent In these the orders that used we FCX to including transmission market, U.S. is sexually the transmitted which and uniquely and XXXX. is virus. will Zika HIV/AIDS get the both FDA-approved condom,

Affordable under We Act FCX and and Care happy both of public to now advantage I’m Our large in the FCX place, distribution available private and access numerous challenge in to in reimbursable retail create efforts pharmacies laws revenue have market the report was new and traction of different pharmacy Affordable XX% that marketing the so and reimbursable to the is under to reimbursement Act. states with U.S. with sales a of infrastructure growing the the country. the is across over opportunity. payers distribution, six Care seeing channels. by take market sales we’re prescription prior

We force primary and OB-GYN sales care have the a marks that small physicians.

HIV clinics. better departments a master who health service have to directly and directly FCX margins, the community to now distributors we covered XX,XXX these with We and STD organizations entities are entities. these like entities agreement approximately There’s signed sell of to of and sell middlemen eliminated XXXb and

by ship center Apple have with can local that a actual approximately, the or an home, specialty HeyDoctor FCX Android a prescription partnered the so be patient product their to ship pharmacy home Telemedicine their via their pharmacy. obtained that by prescription to their or We an with smartphone

continues an have can we that where at FCX purchase a individual and We from to assistance the website. And an program discount uninsured grow. colleges have active our and underinsured finally, program, universities

new seeing the and generated being growing We’re in revenue U.S.

Association ejaculation. of of revenue Phase May the positive We PREBOOST X Benzocaine other scientific Wipes is the meeting XXXX. Urologic and launched press for during X% received which prevention was released from marketing. trial, We results clinical premature media opportunity Our our their by American digital via PREBOOST final social PREBOOST, in

which Incorporated, Medical into sales We agreement also specialty entered distribution organization. co-promotion urology Technologies a is with and a Timm

good now making discuss to been has of President the progress call Michele? and Vice strategy towards the oncology Greco, Michele Finance diversification our company. turn a will Our highlights. become urology Executive over goal biopharmaceutical leading I financial to to

Michele Greco

Thank you, Steiner. Dr.

the of additional FCX was million the First, not for Net totaled launch year the for present as to headcount in of year were expense operating increased and $X.X associated $X.X FCX. margin the XX% programs, million accusation let’s sales million diluted results. in in increased or compared with million the loss quarter to $X.X of to in of compared totaled fourth $X.X $X.X which development primarily unit net year review common our diluted with per compared $X.XX our the the fourth quarter. quarter. The of expenses from was quarter Operating APP million quarter $X.X prior million compared revenues increase from Overall, research a to share, $X.X the XXXX. prior and development year Gross for cost to to quarter. net a $X.X clinical for prescription quarter. prior $X.XX the prior year was and prior XX% common in the compared costs quarter expenses million, million, due in million share per $X.X or loss there

XX the sales For year-ended XX% year from down prior totaled XX, million, million $XX.X was of September XXXX, the unit units. which

from units, Brazil from of prior totaled were unit million of the the million, revenues $XX.X year. prior Net year. Excluding for sales down XX.X XX% a XX% year decrease our sales the

but customers sector by and charitable revenues in government from the prior XX% the geopolitical revenues were The coming million, of years. public UNFPA, on over that a declines funding via we’ve year, recent primarily our of from down uncertainty net and USAID to who directly our those the due from dependent such U.S. the Excluding seen year. tenders, order donations order in our This net political the also of any is volume Brazil source. decline as prior donor caused size decline impacted $X on aid, frequency especially are some U.S. dependent or in timing

that cost net R&D are noteworthy line million, results FCX, acquisition, a in share, $XX.X unit XX% our the margin of to headcount a net base with in Operating expand common for customer diluted improving associated cost. APP cost $XXX,XXX cost decrease the again for $XXX,XXX, XX% $XX.X financial recorded markets. additional was the three income XX%, and optimistic our gross sales. tax result to is prior as common and and from $X the regarding benefit primarily diluted an prescription million, increased we other and compared represent compared in P&L, decreased increased prior Gross work from we $X.XX per of percentage which low of costs the year. primarily We per prior increased to XX, fixed respectively, to year gross for year. margin tax launch ended The months bottom and September The effective the $X.X $XX.X profit due our will of of we XX% the of to million Also respectively. million, expenses unit loss to administrative XXXX, rate profit per see X.X% of of year margin due the for by XX% a million, $X.XX or or $X higher the allocation share expenses, of million to year driven for for

in are state, federal operating $XX.X million $XX.X XX, to U.S. which and respectively. XXXX our the of in UK, net Our NOLs, $XX as million and added for the million loss September

which transfer profit payments we a due in regulations. is taxes Our primarily the XX, XXXX as international during operate ended to September were where small to due Malaysia, cash $XXX,XXX, year tax pricing

conversion, voted to XXXX, In addition, when the July on million stock is of three in there stock actual not The cannot which was shareholders be when cash the date for XXXX, granted which shares which preferred the a dividend. of shares. be preferred the XX, shareholders dividend merger and in a the the year $X authorized does the and of the the valuation $X APP months available recognized the number P&L were XX, for the million, of common the value is October increase to XXXX, ended September until represent XX, represents difference

increase the However, per it’s when an in net computing loss earnings share.

Moving onto our balance sheet.

short-term As cash out $X.X broken of million. balance receivable our and our $XX.X between This million. balance balance XXXX, September and of sheet million was of long-term is XX, $X.X million our accounts of on $X.X

$XX.X in $X.X our capital, liabilities, September assets September to $X.X the year-end generated which September liquidity, program. million XX, short-term We’ve down of million. using We from our each per We’ve balance our the our million portions it in of as and our is our programs. on XXXX short-term is cash made activities million year. which clinical during XX, was from position prior of operating XX, net XXXX, working of XXXX, million versus $X.X compared As progress significant cash advanced $X operations in prior as

Our clinical least, operations. be part, to to programs, commercial available at cash advance plans from continue and our have through our been using in

sector the about optimistic meaningful prospects to operating global expect profit. FCX closer and of the historical We’re to public and volumes return profit near-term

like the Dr. back to call to Steiner. turn I’d Now

Mitchell Steiner

for Thank year XXXX you, Michele. has year a Veru. Fiscal been transformational

have We company. biopharmaceutical urology Veru foundation a established make a to oncology leading and

for drug growth. the at and the new least, five file, candidates be This the We have aspire at able years. engine next same near-term provide urology file to NDA in several to one drugs for to have and shots to launch time mid-term will year progressing and each multiple We oncology.

commercialize new outside products company. products. We – XXX(b)(X) we the the to from outside continue from seek will XXX(b)(X) existing Currently, develop and

cancer to at multiple forward oral look targeted a We’re a excited of about as obtaining time. types VERU-XXX and the right for therapy novel partner

PREBOOST continue will to part FCX We development clinical finance in commercialization and and through sales.

through will market large for expedited shareholder low-cost opportunities development in clinical We urology value and drive oncology. and

and now We’re committed questions. leading the biopharmaceutical to to a oncology that, company. urology open I’ll call And becoming with

Operator

[Operator question-and-answer this go gentlemen, Chen come and will the at Please Yi session. Instructions] H. Ladies ahead. Wainwright. of begin question time, we C. will first The from

Yi Chen

My taking sector on global is Thank the for first question. of sales Thank public you. the my cycle FCX. customers for you question

fiscal so higher then that XXXX by be a XXXX, speaking than revenue year lower will is that two years, to has -- every, a once this is, generous be if XXXX? in is year higher XXXX they So projected typically every have order so sales a revenue – fiscal followed

Mitchell Steiner

great Yes, question.

So has I’m who I’m to five as answer years for to going it see then been forward. company going discuss going I us historically. the with Michele, ask And over to

So the order the that they million is expectation will units, ever. which XX have order going is sought forward, the largest government Brazilian

XX So million historically typical order the to XX is this order – to big of compared million. so a in

So to number. annual be think, that this With years that is an maybe even even get a if months that full I don’t it’s two a order, order. to though we big to year XX said, order would fill that

of a it’s in for XX to three Africa, million largest The second that’s they’re terms years, XXX this year million – South in, units. one going and is three again over order putting units be the

years. this and on but that it that think of it, and I three to – and may look what when we’re for confident Now will we’re go going the go four competition, bulk expectation on years, get to all our at

near-term, biopharmaceutical along from and from getting hopefully and see will VERU-XXX least what that, for Veru revenue next four Tamsulosin our moving FCX. that and from and at we the expectation Tadalafil/Finasteride Solifenacin we’re years, for revenue the wise will the be the to dwarf will VERU-XXX two so, pipeline And and is

heading where the of of kind out I’ll the cycle Michele tell that’s kind how you let Historically, we’re future. lumpiness from a plays So in standpoint.

Michele Greco

said, as look at Right. And you’ll Mitchell if again us some lumpiness. historically, you see

customers. main We have four

As they I to or governmental mentioned, agencies, order it’s been FPA, continue USAID, year-over-year. and

all they down that from which countries on for them no is them, the and up those with countries. are for orders depends So asking place it there donations

proposal, what they if and Our Africa tender a go will. of call – the process, Brazil Republic through a request you South for

because to there’s process that large new working Africa and But ended they’re start. the have tender when there’ll last in And a gap between a sometimes is to a when two put the the that then the a where shipments close ends, the out comes the and gap, those times other between the - past, when like countries lumpiness so will they and gap out South you other next be have we one one is, when And one year customers. tender and tender tender we’ll seen have closed. no

Mitchell Steiner

it’s But million average, historically, look XX to units last XX about on if you year… been at X the a years,

Michele Greco

average. On

Mitchell Steiner

…on average.

to so keep that’s something And in mind.

thing standpoint And premium. that pricing The year put we in this from market keep U.S. standpoint the effort major other year a a is market. to both and U.S. behind is, the mind is reimbursement a first

I traction so, six shown in And as we proof-of-concept mentioned channels have in a now the have we and that call, revenue.

the global U.S. the seeing what very in So we’re or easily match could market. surpass market

And careful right confident we our and to that. so, able with if will realize being time resources, you’re be with the

opportunity So, pharmaceuticals. – the will there’s us it to here, bridge an into again allow but and

Michele Greco

We’ve to large then, entered other And is distributors the into new I globally. markets. relationships working that, globally during been mentioned new with thing call expand we’ve the that

exploring We’re new markets globally.

distributor They’re going Pakistan. So be Mexico to DKT, have looking America with new eight and South in we countries working [ph]. serving also at a

exploring opportunities and Asia in We’re America. in Latin

distributors, arrangements, we’re and So on new working new markets. new

Yi Chen

second ramp soon reasonably what my FCX words how to U.S. going a XXXX, expect revenue Actually, question is see you. the in sales the up in we of in or Thank kind in expect we XXXX? can to be of can other

Mitchell Steiner

kind what are of understand The we expecting question. XXXX? revenues in I is the question

Yi Chen

just the be U.S. that of comparable just mentioned the size you market you you in about, potential the…. to expect could because talked Right, FCX

Mitchell Steiner

yes. Yes,

Yi Chen

right. sector, public Global

Mitchell Steiner

Yes, true. that’s exactly

U.S. revenue. each different are this we’re We channels, call, And April. in the and at we looked the so in those seeing six what of is, producing I as now in launched year channels mentioned

so specifically. need our have months to literally answer under or So really two here question actually can can and and see eight about that growth your quarter now belts we another project we later, how are we that to we

very, we’re we’re So excited. very being careful, because

We’re bit it one we refrain statement [indiscernible] under more it until is promising. guidance these but in making data going is seeing growth a have our from but channels, we’re each of to natural little belt,

Yi Chen

third it. Tamsulosin markets Thank the you. got My patients are and question Tadalafil/Finasteride when combination DRS? markets compared DRG long-term the is, how to Okay, capsules, targeting of in facilities, for Solifenacin the the large to care

Mitchell Steiner

Yes.

you on FLOMAX in for the the million So some out year, U.S. for million alpha which are Tamsulosin home. is XX so Tamsulosin, a recent I can okay. data XX on tell for excuse based was data it’s roughly nursing sitting that I’ve the IMS blockers. in generics One it’s me, of In looked men it comprise prescriptions and enough. XXXX, XXXX, XX at, Tamsulosin prescriptions Tamsulosin,

And so about prescriptions million X is that number roughly a year.

but If the question, homes XX%, that’s XX%. The not number used answer tablets? in swallowing you is asked how are the nursing many men

take are men cannot have take pills through go is can’t a that there million who diaper X men they nursing or in surgery. about million who sitting and catheter So BPH. there have to pills X homes homes nursing in they means have would the Then

have will is cannot men prescription about that and or granules some million there’s tablets a X those. of X X by about are powder who represents in get them in long-term what available slow blockers numbers of care think, or swallow – settings, home nursing we’re the million the number. swallowing million alpha a as using or that’s four three a So not prescriptions new other difficulty big also We because year

So maybe or there million of X something million, that. maybe north like so X.X

women. up know, it you you open as Solifenacin, Now, now to

not it’s with men just So BPH.

and very now are Now dealing different. drugs with women you’re these

know, is, flow because restrictive. BPH you the the is urine As of

the keeps Solifenacin doesn’t squeeze to as taking of a is wanting overacted, bladders care and is bladder storage the it and facility. act meaning

And Solifenacin, bladder, up it having by like storage. you a of the relax a so drug to more be open can

fact, with bladder. take In drugs to also can men overactive BPH

homes, With dealing we the will could women. that in there said, both market not so men not similar, with overlap. would it’s So mutually you’re that and nursing exclusive, imagine they’re be be larger Solifenacin because

Yi Chen

you. Thank it. Got

Mitchell Steiner

Thank you.

Operator

Ladenburg. from The Kaplan next Please of question come ahead. Matt will go

Matt Kaplan

Thanks the Congrats during on XXXX. progress my taking question. Great. for

Just DRS. a follow-up on the Tamsulosin

In of well? overall on or formulating as the that, Mitchell, strategy market outside well your as go facilities, care opportunity market long-term you there is a as tablet terms an to after of capsule focusing the contemplated

Mitchell Steiner

Yes.

has answer is is Then is, pretty exciting, just of in because of as outside have appeared And a don’t they and medicine fact issues stomach patients advice doctors, take they to pass an dizzy Tamsulosin know, not always we our food. they food out to be the getting the the on with taken with that’s a it the of and this up that because, like empty biggest that’s take and So you end general problem. effect. and one

safety. effects certainly administration the potentially So compliance to be a help able to without and food with have something

in formulary, long-term or capsule a that, and have we’ve tablet capsule. formularies granules out using be where really that’s to food But to focused nursing right now then granule not powder nursing said a the effect appear going found on really to we in we need generic is with that and/or it we’re got with not because ourselves, a food have nothing, you these great, if because release in we homes powder slow powder, if which means the powder Tamsulosin, on homes, wouldn’t another gets did the look, be when requirement, formulary. So the a – sliding why the boy, care, do come

that want could nursing these get for capsules they to be they and are every in fall to break and patients on because long-term certainly, potentially care, of And that breaking admit the nature. that to pharmacies homes able we’re hip fact don’t one things going So of of to alternative. formularies, don’t their have in giving the the

powder legally, a want So for available. they’re have medical, to going to

swallow the out that vast found are nursing capsules. have and if was be primary patients majority those nursing home pills, we gosh, of going outside urology slow setting what release you granules in to can what the So my patients care, that, swallow of home in

putting the a we’re capsule. So back granules into

broader you a then want we Because buy data. and question that to to can’t in not, easy –again, because point and do infrastructure. and that, go primary that demonstrate into if urology study, we we And the capsule the they to markets can and sales do vitro as we do. has quick in clinical FDA same company, much the have the force capsule bridge broader don’t to So a to want drug primary The way care care to if a in get the after as fixed But the equivalency big going see inside initially go markets. dissolution study that’s what into a that’s urology real company? is, a the is as we’re can

to service XXX, about you that, partner people, nursing think account when But when in we to that nursing XX the XX probably about And may is with all primary urology the and could you’re you with same you the start fact in it we same sense channels, technology the setting in managers. people, start now home that talking can care through XX Solifenacin are partner existing and urology and talking care. homes I Solifenacin out that primary using Solifenacin sales forces with basically Tamsulosin the attract there. that long-term at can scenario care now significant that’s sales already make in bundle and manage

Matt Kaplan

of in then help sits little for that prostate terms of VERU-XXX, your a where the Thank of helpful. plays terms well? And of gears shifting just cancer, how that us proprietary All programs, you in, in understand can right, treatment some you. that’s bit

Mitchell Steiner

Absolutely.

therapies cancer, a exciting that prostate for period. effective advanced the and blanket most statement, part. in have taxanes hormone make urology cancer prostate the true been We in here’s So – know a it’s and therapies statement

when and and So fail, to to cabazitaxel shown docetaxel activity. go overall survival go hormone then and means have therapies that okay. And then they the they cabazitaxel, docetaxel

because really related there a or not so docetaxel abiraterone castration it. them they pill they androgen they out now it’s abiraterone, the through, then they means have the it’s oral that And disease to relationship then muscle the that, urologists other giving and that and given break urologists and like have get they the drug because some with much therapies, recognize involved then issues they taking to deprivation their to weakness, on And hormone now enzalutamide to to have neurotoxicity, the upset, do, the or the go hormone LUPRON so cabazitaxel with get LUPRON gives and And go to care to castrate start the to them. when into neutropenia, fact pretty also patients. similar the therapies they enzalutamide, problem and end ideal. to and urologists. with besides been in oncologists so therapy primate patients of they all of with they primarily have They have when fail a a of medical IV losing them are which intravenously, then ways send therapy, And

cabazitaxel that in was There even of XX% patients XX%, square after I this showed the well continue because a has fact think, those prostate, would ideal, Now these abiraterone. mgs we our by agent, at that that from an the allow know men oral in they fact, recent for having almost of to publication looking basically therapy it from who we fail the and models enzalutamide/abiraterone. who that’s activity prostate to in abiraterone in in activity a have And failed will Mario know urologist taxane-resistant in to enzalutamide responded actually we’re men anti-tubulin failed subpopulation Eisenberger, – me cabazitaxel. the animal be cancer has they that it’s XX low-dose,

response So to have men we aging failed blockbuster. a given had was rate that had an could enzalutamide, be be abiraterone and similar that that that would a that if oral

prostate want setting. the in see that’s we what cancer So to

if ADT further, get enzalutamide squeeze and keep and because bang for androgen post-ADT, much testosterone help we abiraterone if because know failures, have squeezing going, deprivation it and to you we vice and buck, don’t you it you going your add way it’s versa. enzalutamide, So down you abiraterone fail more not

activity like oral taxane can turns tumor a we’ve XX a So that in anti-tubulin adding make publications. types, now out in also It big that’s it shown the difference. other

you types, anti-tubulin And a opportunity. bunch the gone with to tumor which can to value VERU-XXX the also then add of whole of prostate an specific, prostate opening said, being if from only just up activity so will as you’ve to show oral

with endometrial why they’re other ovarian, opportunity, and study and we’re lot like breast in start right the discussions want Hopkins to anymore, trouble beyond very Johns pancreatic that’s having now others clinical cancer, we’re just us excited of having to an XXXX that a chairs tumor they’re on. And because world the so types with and So that don’t in moved in IV cancer in the in sit going about with patients has that help to this. taxane, like oral

out So some It we tumor But utility see want activity how so to have to even of can such study we an of that to Phase the addition tumor across across to be taxanes X this to we broad because other opportunity in able prostate, really responses, like, we’re the want make types. gives safety show show have we product. the start in part many us PSA types.

to hopefully, this towards year, so seeing data. start end of going And those we’re the

we And big this company, coming going, the – XXX(b)(X), coming so value. has part money have program the make in. But we’ve so, the more of sure for the we enterprise and have is so potential in FCX revenue got but that we biotechie

base And and so to something but look really VERU-XXX really building floor it’s we’re a a – is forward, exciting product. nice

Matt Kaplan

Mitchell. Thanks,

Operator

ahead. from The of H.C. next Wainwright. question Yi go is Chen Please

Yi Chen

you. Thank

the you to fiscal study the significantly do a follow-up. in and than the additional and Was operating XXXX, for above equivalent in XXXX XXX expect expenses Just XXXX? all trials XXX quick be higher

Mitchell Steiner

getting XXXX, we’re I we’re the be because than products. moving that finally the to to now point expected it higher

bioequivalence easy said, that small. is and do with study and they’re to non-expensive Now they’re

has In about can going $X so budget, what big it’s to million. expense we’re big XXX around means. our be the VERU-XXX. expecting So VERU-XXX, that expense, Veru and understand a you patients, roughly in

not it’s huge So numbers.

Yi Chen

you. Thank

Operator

conference gentlemen, any session. closing question-and-answer like back Ladies turn to for to would our Steiner this I over and remarks. Dr. Mitchell the concludes

Mitchell Steiner

today’s very us appreciate you progress forward Thank and look in everybody joining call much. I on I you. next Thank to our investor’s updating call. the on you

Operator

U.S. will be The the time digital and noon of X-XXX-XXX-XXXX in Xth, by beginning the internationally. available Eastern approximately X-XXX-XXX-XXXX dialing January today, replay conference

Please for to be name the attending will has and replay XXXXXXXX. conference prompted concluded. record your The be enter when company today’s which you code, You’ll Thank joining. access discussions. now

Veru (VERU) 5 Jan 182017 Q4 Earnings call transcript