Samuel Fisch | executive |
Mitchell Steiner | executive |
Michele Greco | executive |
Leland Gershell | analyst |
Good morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fisch, Veru Inc.'s Executive Director, Investor Relations and Corporate Communications. Please go ahead.
morning. Good on may made forward-looking conference this statements be call statements. The
cause its included not may may objectives, those to, may and actual or any regarding forward-looking interactions, CEO statements include, Chairman, as and Mitchell forward-looking I portfolio. that statements results to risks in and like turn necessarily and expectations operations, contained releases suggested XX-Q development finances President. projected, but Risks differ intentions and are would to plans, our well press Forward-looking to Dr. are Steiner, actual Such company's time. the XX-K and results from are limited Veru uncertainties, differ product our materially time our regulatory significantly statements. the developments filings statements to conference or Inc.'s or from now known subject business, to as call unknown in in SEC of and over
on are joining Executive and Vice call. Chief Executive General this Administrative Investor Fisch, Purvis, Financial Michael Good the Corporate of morning. of Thank and Corporate Officer; Communications. Counsel morning's Relations Officer, Greco, Director Barnette, With Dr. the President for Scientific Michele call Sam me Chief Officer; Chief you Strategy; Gary and our
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at sheet. let's balance Now our look
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notes promissory balance $XX $X.X Our our accounts the Entadfi and receivable million receivable gross were million. was from of sale
$XX.X XX, XX, on to XXXX, $XX.X capital working June million net September XXXX. was on million Our compared
at payable received Bluewater Biotech April $X payable of for payments. milestone million We for $XX up the September we XX, entered by of XX, million the is XXXX, $XX.X $X we for with in period. million cash our April XXXX, and in X prior million closing year agreement by $XX June used to $X $XX.X plus operating During possibility million operating sales months an assets to there activities purchase September On asset million in by XXXX ended million the payable million. to into compared Entadfi $X sell activities
Fund, shares Lincoln company's the purchase obligation sell Capital not LLC, company On with with XXXX, our provides the May to million X, XX-month we agent, a agreement million. which value Jefferies the agreement stock open XX, an but which LLC, sales into stock of issue common a market to Lincoln to into opportunity entered up and May stock shares right the sales over $XX On company the of sell period. Park time we of of with through with aggregate up $XXX to the provides common to a entered Park an Jefferies
an sales sales size by our the time common time sell will limits to sell meeting any based price use and the $XXX On of in authorized a of us. XXXX, July number from in shareholders or normal with time obligated not are the to stock company's practices common XX, of million. company's shares shares Jefferies agreement. which shares efforts instructions, We approved including upon stock specified under to we its consistent million of reasonable $XXX commercially to Jeffrey from increase had any special stock trading
net FCX driving platform in demand and telehealth the future the increase through and for a U.S. own in distributors marketing revenues pursuing our the increased for FCX sector. telehealth of efforts to working additional are awareness We prescription channel growing
year. as see an under result Brazil agreements starting hear executed have to later a public of U.S. in expecting sector business calendar see in are tender are last to sector public increase increases from started the the distribution in our the tender We new to about in year and and within a global new
and time the planned months assets. to for sales our drug of current or spend try match slow resources. available balance, development for acute of drug tools one respiratory at the financing Entadfi program managing treatment We our we our the adequate breast to novel received of have, from company developing to with diseases. we metastatic FCX, the to revenue effective of cash cash needed, drug syndrome development cancer on viral-induced the and Over next one experience fund for had focus focus believe continue payments will the as plenty distressed XX along will operations be years, cash have to be secure with the of ability we and sale the on medicines the the of in to from down burn is a if
to Now turn Dr. back Dr. the to call I'd Steiner. Steiner? like
Thank you, Michele.
FDA approval alone primary the combination Phase for the past in Stage III demonstrates we'll received from clarity pathway. active either by with of enobosarm takeaways then ENABLAR-X quarter trials, obtaining in Phase ORR, regulatory for have the abemaciclib abemaciclib we Phase improvement combination plus are, treatment enobosarm III on accelerated the breast major If metastatic portion versus control hormone and potential this HERX- meet X the evaluating we've FDA cancer. receptor clarity key significant or focused end as the III therapy X enobosarm second-line So point agent for study, monotherapy, on nestin-blocking with clinical
the We survival Phase progression-free primary of Stage confirmatory endpoint. will portion initiate with study as III X quickly also the the
life So remember, and different with targets the breast enobosarm agent without with effects cancer metastatic that in unwanted is quality improvements massing hormone the thematic associated of a new and angioreceptor androgens. potential increasing atypically
that a have III expand and in Phase meet the gain company help had larger COVID-XX COVID-XX ARDS, to and This certainty the Given medical agreement available study with study ARDS. more and of will us would to opportunity. market confirmatory oxygen patients against offers of the a large enrollment of all treatment landscape requiring the and beyond patient other include evaluation viral-induced with current to of COVID-XX benefit all need types the who with potential would supplemental hospitalized types in the for unmet infections, a viruses III FDA expanded mortality timing viral-induced risk into lung Phase influenza, in September sabizabulin RSV,
the to The positive reported is A virus sabizabulin notified FDA one XXXX. and finalists meeting efficacy host-directed preclinical the safety evaluate to trial for emerging planning of XXXX. large is poxvirus disease we a smallpox therapeutics ARDS. companies ARDS X novel during induced hospitalized Influenza an is with and of multicenter division infectious scheduled August of placebo-controlled clinical threat-agnostic influenza and expect BARDA for calendar for as the selected of patients be Veru and adult for to QX pre-IND and the decision We data
we we the compared position, the million, declination. cash successfully COVID-XX burn during million reduced financial reduction after was $X.X EUA a company's expenses $XX.X The quarter. have this prior to received quarter Our
year $XXX sole with agreement, to to million stock of And purchase with of Fund. in we Our and plus fiscal is in terms QX of up the -- the for this time gross was XXXX receivable $XX We up Entadfi discretion our XXXX million stock common $XX XXXX to XX FCX are value Park financial receive common of sale Veru add Capital continue into also Park $XXX Lincoln million year that further enhances long-term health shareholder from under strategy million, together, for a million. get at the position the plus, cash And fiscal is expect committed and with Veru's time expect notes the to $XX promissory commercial sexual from we commitment Veru's to entered flexibility aligned the believe over purchase you our business. agreement creation. contributions you cash to that And Lincoln months. for purchase our
potential and open Finally, capital. another partnerships induced I'll in breast some of seeking viral and questions. ARDS enobosarm cases, for Operator? as source we're call already now With sabizabulin non-dilutive in the to actively discussions that, with cancer
first comes Instructions] with question [Operator Our Jefferies. Dennis from Ding
Two Dennis. questions if This from may. is on us, I [ Anthea ] for
on DTS cash, First can much OpEx how do rate your you mono one will of guidance have that? you on see second, beyond status the run trial XX And on on breast to potentially flexibility and if we extend cancer, data months? comment the of from
cash. going to Michele question ask answer. I'm to So a about
So Michele, can you answer please? that question,
payments on and space FCX based that have sector the based due answer sector global the with Right from is the the we making all now, the seeing with Sure. runway, The I on the a FCX the Entadfi. portal, beyond than for of improvements what for product, seeing FCX in question we're said currently. our coupled the sale also on increases cash, no public we're our fact based changes public with XX-month the we're different U.S.
We continue expenses. operating to our flex
look We continue make improvements. ways to to in
as out again, time I issue see we look we XX-month -- don't beyond so period. any And the
want add Thank just that. I to you, Michele. to
a was $XX to shareholder, So very dilution. sensitive of for mean, a been then us. money. and dilute mean it million million base that's And $XX to to we very, something $XX million. shareholders. result, again, year health And and million. sexual $XX went don't prior I continued had It $XX we $XX has real there to so big we're that, our base million The our generates a and be as very we I'm success, peak then business. to everybody's refresh and excited about memory, I million, this to And business
-- public I U.S. the birth we control the Affordable happened growing -- we has business, reason, control really, not business the global sector. for But in demand found Act incredible mean Yes, from prescription of business got have that we've way. and in For mean, it's got sector. nonhormonal women been public business our Internet have an I growth over. yes, more U.S. Care that that
the be right So the we to happen business right at at time. just
And go so we -- are numbers based on our numbers, going to up.
but good see XXXX, the we so next a mean, year. you latter XXXX, Phase And into be ports pretty main being XXXX with job I doing XX helping to move portal the mean XXXX should cash part -- I for of as better programs. develop a good continue we're months, us helping a job for to good FCX in X the our pretty did the at III us
to which test. our your about is As it relates question, second
found population a estrogen line later patient is in what they to Later-lines inhibitor ENABLAR-X. And agents. a just than what test So clear, be enobosarm our and monotherapy at failed blocking to as CDKX/X least is we or study, still XX cases, some patients in that and approximately on we is, X monotherapy the more. were There's on in they or there's that patients study speak. enrolled X
for us completed have we And report. study so in order report clinical to to data, the need
data, population, access encouraged. monotherapy get conclusions And going some make much later-stage at about that to enobosarm carefully to so can then a we're yes, but study once clinical the this data we're very, sure look very we have in that before to we patient we make
And so we're looking forward to seeing that to report that.
with Chen from Wainwright. comes question next Yi Our H.C.
on of is behalf [indiscernible] This Yi Chen.
the you question overall range in order a like portion anticipate ENABLAR. Stage Do receive of X an a range accelerated first rate certain study you on The the to see that from to response -- minimum approval? would of
it's good. Yes,
So as long as we see stay hypothetical. to hypothetical, happy I'm
could And our on basically the is active, with is be? So arms, you at based the you then the so think what literature. this look question X we do the start rates if ORR again,
and population has agent you is around population, the have for active this because expectation the going blocking most that inhibitor be to elacestrant second their at patients estrogen second failed lessen the the recent group I at control X%. actually control blocking agents And -- and came their out X% and based the about active is X% patient failed if elacestrant was to ORR. where control CDKX/X that given patient X%, on alternative CDKX/X ORR agent, inhibitor estrone study given patient line the the have with look So blocking were SERD is in
that finger the that's we probably most study So X%. say large can to recent that's point our
X%, As to relates with combination that abemaciclib in not probably around and in exactly is but abemaciclib like enobosarm, is close. that's this population it alone one,
And so X% by itself. itself. But have abemaciclib by don't we
We plus enobosarm. have
that disease is interesting, started. expectation just first X got enobosarm can considering pretty our we're and patients abemaciclib our have partial So plus X be stable responses in we've getting
CDKX/X or you back in doesn't the much whether looking to just basis percent were and when than patients the then is This look the XX% women a responses, to objective you product. XX% So at by the you on tumor in going on the II, it XXX done was we were REIT mean matter, XX-plus go for the cut for enobosarm itself, we it's well, tumor data. is why to higher only REIT And expectation look licensed be I depending study X how And responses. we that Phase it's our at much, control. have to when where active inhibitor. II
so looks that's So it you it at when X%, good. was And monotherapy. versus pretty look always -- XX%
in think be of can to that be neck active abemaciclib much going we enobosarm neck. to So monotherapy control, pretty for we're range X% and
is ahead, with quality has -- that enobosarm, build And that includes in combination muscle, medicine. itself builds enobosarm chemo. if more is like well-tolerated bone, And very a good GI abemaciclib neutropenia, a with happens, by but life. medicine and again, a and so It it's abemaciclib very thinking just I'm again, issues of
high monotherapy go were we safety it, number to of combination, it's may we with go a quality with of if we the pick enobosarm have combination, enobosarm able it's just to the and this and similar So forward and because monotherapy, we have a life. it
all how thinking So about of is of set up but this from we study. we this we're how is standpoint -- a the it have hypothetical,
FCX's And you if lastly, missed prescription I'm earlier prepared I provide remarks, please? the quarter, this your could in for sorry revenue but
the the What's the prescriptions quarter. Yes. question? for Prescriptions FCX for
So said $X,XXX. I just
Got you.
that. price with get -- That's and -- good. I'm yes, and up X,XXX means that good we very and pretty Sure. that's slope so we're going for because happy that that on
Leland Gershell next comes from with [Operator Oppenheimer. Instructions] question Our
questions. to couple ENABLAR-X, respect I of wanted With to just understand. ask a to
So combination, evaluating -- since are into now starting Or were initial just work towards patients you you you been those X patients, to Stage you the as X you as as those patients? have enrolling the additional enroll type...
what is results. got We this So happened. the
make X preplanned to of at look in, first have there's sure abemaciclib patients PK. We was enobosarm time the the call the interactions we'd no with with drug-drug combination it, XA, Stage be the to which the
have study that's patients And we second you monotherapy, dose. the X come them II with and the milligrams picked X as and that data at the there's So showed together we the interactions, new approved stable line first responses to we abemaciclib enobosarm because got you X first what we in the took put did responses week -- X Phase position. scan, the we basically issues. in the shows we the And and drug-drug partial We even no no And show in back partial showed scan. safety disease. in X
back FDA said, go dose and than good, interested so the don't looks came X%, in FDA higher but to more optimization. very we're the higher, X we get go And basically, to and clarity went don't
optimization the want dose on done milligrams and was For sorted XX X a picked to we Phase -- out. registration dose was our have based II. program, you they milligrams in that And
lower. go said they So
because will with monotherapy of the agency were a is what enobosarm we abema so that X and and the that and anybody doing you you combination to can And X a to in will enobosarm abemaciclib combination, going -- and enobosarm. milligrams the enobosarm monotherapy. look milligram what And doing out monotherapy, in tease enobosarm allow at allow have combination enobosarm's abemaciclib
did a reset comments FDA -- actually I wanted meetings on sure of of the get get with right. X a bit little to the from clarity, it the we to back of all to that out. So couple back we make took sorted time comments FDA sets and
we X clinical supply when where is X enobosarm are now quarter And milligram ready. is so enrollment milligram the will up again pick and the next
that's So on. waiting what we're
to did the Okay. see you Understood. And African the just additional South may remaining FCX, tender you Brazil of with respect public potential the and have the also payments of value the side as what you comment tender. if on
Yes.
actually Michele expert. the So is
we to comment that. historically has general Brazil. And in one. about in can so to she's the Michele? tell tender South her happened expect you much African I'm think have she'll then what tell going how and going how on the from to But And
Sure. tender. a portion Africa tender South just that significant won We The of started.
And started. tender X-year so sales process, a have a It's the so tender. X-year just
units. So XX depends of million into going out we have distributors in a tender bid. category. In to year. of in area we and government most the Africa a government And between much multiple the tender is bit partially well, for a of towards to the normally with normally new how tenders new South that out the fall to take due put put the be of and coming lot the Brazil, of is change that little and break to for in a to and as you portion all end tender the time continue XX there. supply their on they calendar is instances, non-latex this It million they tender product
we other sector So the a in portion female get opportunity tender the condoms bid an are public on to located. of where global
supply that And lasts XX so months about that. to normally
of following it's will like fiscal half second all a announced distributing, so going the is we tender the and our should year be into start said, year of tender to And word though year -- the be next in this towards year Africa South that that process into end I the once year. as well. continue, next The our of
that is Yes. XX we'll going It's for years. And expectation after the continue that. been on
ones out, to the going one. going. put keep it's just it current So would extend new It's
it's it feels and we're largest that's the growing So summer, our U.S.-based prescription a business, margin. it seeing and good. is to business way it, palpable, that's of and and think in profit
The that that public XXB sector. have past. up ordered is margin XXX%. profit and we ordering kind largest the Big new It went business, of some again. departments stuff. health then of up picked And second That started in U.S. not
good. feels that So
So our margin. second biggest profit
I to everybody after With And a masks to all vaccines was it that dollars and all then sudden, go using of COVID, attribute stuff. their COVID. and
with people clear. to Now tells primarily you than see with, out, probably think true because And that's I sexually freed normal, which very and to the FCX why and that, new more of in are South that's back to public is we stop going #X that birth the ability to the using being we USAID, that's with probably Africa health it passed sexually kind The line is resources in condom is name but transmitted diseases that's big are getting related and diseases. for Brazil just work control. a people transmitted sure, and organization is kind reason of the
Ladies and Mitchell over like gentlemen, I for Steiner remarks. Dr. closing question-and-answer turn back this conference any session. to would concludes the to call our
on us our to Have joining you afternoon. great Bye. today's updating everybody appreciate look all I next on operator. our call. call. a you, progress of forward Thank I investors in
now conference today's for [Operator you concluded. has Instructions] call discussion. attending The Thank
You disconnect. now may