Recent VERU transcripts
Associated VERU filings
Sam Fisch | Director IR |
Mitchell Steiner | Chairman, CEO & President |
Michele Greco | CFO & CAO |
Brandon Folkes | Cantor Fitzgerald |
Yi Chen | H.C. Wainwright |
Good morning, ladies and gentlemen, and welcome to Veru Inc's Investors Conference Call. [Operator Instructions] After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Inc's, Director of Investor Relations. ahead. go Please
statements forward-looking The this call conference Good made be statements. may morning. on
may not unknown may intentions those Forward-looking statements but subject actual product include statements are results statements forward-looking uncertainties, company's business finances, are objectives, and portfolio. company's company's Such of known necessarily from plans, expectations, and the differ or and significantly regarding to operations, and results or suggested, and that Chairman, risks actual to the to, projected, Inc's would limited CEO, Veru included may contained turn are over forward-looking in XX-K to Mitchell conference the I XX-Q to Risks statements. developments and in or any filings. now company's President. materially like Steiner, Dr. call differ cause the the SEC
you and and the call. developing on novel joining Officer; Thank cancer on Thank met, the of management Fisch, Michele Gary good call are Investor our for CAO. prevalent me focused Legal; a of CFO cancers, Scientific Director Barnette, cancer. two Veru late Chief morning. Vice-President, morning's Sam oncology and With Greco, prostate Executive this company medicines and Dr. Relations. you've of for most clinical-stage Greenberg, you biopharmaceutical Phil Sam, breast is
of year then first for provide biopharmaceutical shareholders upcoming submission record cash current our invest highlights This quarter cancer can of the pipelines, into morning our the XXX and realize the our prostate quarter sexual health a maximum generated clinical of company. to breast NDA continue our another health record the We progress of development treatment so, drug we the candidates And Veru high-value our financial we from fiscal commercial of oncology TADFIN. our from that cancer XXXX. for business for will will sexual oncology discuss value drug business, COVID-XX,
in adjusted financial up in fiscal year should some QX compared which year QX fiscal operating million, of XXXX is is year of US $X.X $XX.X QX income FCX includes fiscal XXXX, PREBOOST million gain of XXXX now sale fiscal on the sexual compared QX the $X.X business the year QX Fiscal million revenues was an million $X.X That in $XX.X of Fiscal business QX which XXXX. $X.X net $XX.X Profit was million, and XX%. QX XXXX million the prescription up of $X.X operating the $X.X in which operating year be business. XXXX to on the We of fiscal Gross the in which XX%, income highlights million of QX had the gain sale, PREBOOST was XX%. the Veru's Let's of for of in XXXX focus million health year $XXX,XXX which of XXXX in sale is on year up million compared excludes compared in to a fiscal to to year loss
QX for tract an tadalafil which finasteride capsule and erectile both in to FCX fact, units while year to continuation year US also dysfunction trajectory contains the increase of sold the XXX,XXX a XX,XXX of by mg, finasteride. combination fiscal is prescription TADFIN It we of in growth X infections give units QX which hyperplasia. for being lower mg tadalafil XXXX, sold in prescription treatment prostatic fiscal US our of X the XXXX, the treat XX%. developed benign urinary market, is of FCX In sense is you we market, approved caused
the submit next NDA week. expect We for TADFIN to
launch new approximate amount TADFIN We when channels of received third-party this and prior and a therapies launched We plan for prostate to via in chemotherapy providing for waiver also PDUFA Veru. approved for be both breast revenue following million. will with to additional therapy safety -- and profiles favorable to of near-term IV the source novel submission oncology, if for NDA telemedicine to resistance FDA a cancers. but PDUFA focused oral in fees proceeding $X.X In advanced are endocrine we the
calendar years efficacy of neutropenia, results X in approaching cycles become four still men excited who Phase cancer being but Xb candidates agent-resistant who oncology Phase appears crosslinks cancer. Veru-XXX neurotoxicity, recommended breast at as study registration survival candidates Veru-XXX a months. of enrollment objective study there prior Veru-XXX milligrams diarrhea. in the make castration were There to an with all manageable no daily men alpha as progression-free administration report X were enrollment continuous new with continuous trials to treatment of cancer proceeding there cytoskeleton. Veru-XXX safe. The indication androgen a is completed The dose study feasible or IV advanced our chronic of and entity targeting continues drug daily the and feasible Veru-XXX declines prostate first-in-class disrupts the be drug the durable on to Daily of including and XXXX. to five well also well tumor and cycles. company in objective XXXX, minor additional making cancer. registration cancer clinical Phase deprivation dosing are advancing Phase a response receptor receptor with Veru and and promising agents, milligrams There is chemo, the androgen reports clinical and potential ongoing the cancer, studies. has and study of without neurotoxicity Veru-XXX and clinical metastatic continues for receptor study men chemical on resistant study dose, men still and reports evaluated castration targeting September into PSA our The total we men open Phase based yielded that Furthermore, an the dosing as of COVID-XX the Like cases Xb, safe. progression. have of as the responses including prostate X have and In for had and X and XX.X is oral clinical XX prostate median show for PSA Xb tumor in additional single partial for and advance prostate Xb responses are Veru-XXX, administration clinical therapy results The to safety efficacy Xb in cancer drug of responses. completed metastatic -- agent-resistant as clinical for subunits daily Phase clinical observed androgen and oral good no X the Thus in also profile. trial X efficacy safety neutropenia. androgen studies In prostate year of label well objective complete to durable XX-day Veru-XXX in trials is microtubules grade metastatic two activity for Phase although Veru-XXX a Phase diarrhea. targets to declines ongoing. disrupt continues beta-tubulin XX radiographic and fewer prostate results, XX Veru-XXX clinical responses. the to and antitumor the targeting clinical Phase and chronic We At three registration XX to and study have results the commence Enobosarm is castration-resistant prostate recommended drug with least responses as registration clinical strong cancer show four is the anticipates indications the progress approximately and for as two patients Phase
Professor metastatic ASCO of of Kimmel who genitourinary agent clinical prostate Cancer place the the Center of by X updated We will presentation Markowski androgen receptor the oral as who Abstract have investigator Mark in cytoskeletal Phase the results XXth XXXX will castration-resistant symposium presenting study cancer is and be in the cancer be an Oncology; taking Phase the Johns Hopkins as disruptor at well clinical Veru-XXX on trials study. February XXXXXX, and an Dr. the through and Comprehensive Xb principal the done is XXth failed clinical targeting Assistant
XXXX is will metastatic metastatic X the its targeted anticipate of and selected prostate have approved regulatory cancer primary non-metastatic received agents on pursuing space to the Company of in control that Phase progression-free note metastatic III the patients pivotal to castration-resistant and androgen-receptor-targeted study input FDA calendar clinical prostate with Veru-XXX first they XXXX. a to the to alternative dose the cancer men of receptor FDA as we active open Company prior pivotal be III, failed proceed cancer of for currently X be of cancer prostate data that we're quarter the X endpoint the in cancer. Phase survival. the radiographic IV and trial. have When The is now design chemotherapy The opportunity treatment to input, Use that cancer. with VERU-XXX. receptor for Phase the resistant from was Phase had in FDA receptor-targeted be for sample Phase allowing are evaluate have As both enough radiographic protocol July the already has progress size become study prostate and of sequence prostate agents the will and Veru-XXX an also using study. The androgen-receptor-targeted leader progression-free the meeting for have in planned men. called VERACITY these of have reasonable a prostate treatment an for VERU-XXX two agent X Phase very and an cancer X settings The cancer. prostate targeting indication with label safety moved design starting the the at fail randomized endpoint positive hormone-sensitive Phase XXX VERACITY primary prostate one treatment castration and the year for Company androgen-receptor who in to castration-resistant androgen-receptor metastatic agent-resistant for pursuing earlier of men indications androgen that survival in and castration-resistant acceptable, clarity agent-resistant study indication agents pre-chemotherapy received targeting the metastatic advanced androgen as real targeted we By and or trial one agent the It approximately agent X an study interesting for will who androgen by in and the clinical receptor androgen targeting resistant is castrate submitted indication have may metastatic Phase efficacy
So, lead indication. all to roads this
is limitations deprivation Furthermore, is and the used prostate treatment deprivation deprivation Phase as currently treatment approved or GnRH mainstay one-month chemotherapy continued the or even formulations endocrine of as cancer as ADT foundation the disease. are the for course radiation is antagonist commercially beyond known treatment X advanced of is are therapies for duration. depot depot available a the If gonadotropin-releasing Veru-XXX the treatments ADT. I treatment no to advanced as throughout men therapy other update is Androgen There commercially androgen the current XXX you will Veru-XXX dosing subcutaneous added peptide, registration to second of of begin study Next, Veru-XXX evaluate therapy of GnRH month half designed calendar stopped. of of is prostate formulation on antagonist to the in to address first androgen in cancer. year study Phase XXXX. year long-acting X calendar three XXXX, a proprietary novel palliative approximately and in half anticipated anticipated start injectable the hormone,
suppressor that cancer breast the establishing is scientific by It's which a with breast which cancer breast estrogen and are androgen and by standards cancer and and strongly headed inhibitors. when the recent most androgen now team, with synthetic the X/X effects, clinical targeted including of treated over they more Hickey common will Interestingly, main receptor different is treatments demonstrated use agent hematocrit, Typically progress is one What negative in decades. positive, eventually explains This receptors enobosarm and estrogen of receptor used evaluated agents receptor therapy. of fulvestrant non-steroidal study cancers. metastatic for her like five of therapies suppresses Nature Enobosarm like been non-clinical in means publication include approaches than cancer This represents develop chemotherapy. Consequently of AR toxicity tumor Phase and Veru-XXX. studies cancer estrogen CDK of treat and advanced target XXX international that discuss is targeted advancement extensive of stimulated clinical but activating several of anastrozole, new lines of breast entity viable in evidence XX cancer progression, estrogen-receptor receptor in positive, tamoxifen receptor than metastasis. degraders targeted being receptor but positive the selective the breast receptor, the IV breast Dr. involving aromatase in cancer breast to positive proliferation, a type treatment selective their our of like advanced includes the X/X the the receptor has androgen. I as selective cancer. separate Unfortunately, that prior therapy being SERMs activated inhibitor be Contrast receptor treatment clinical over patients. chemical for unfortunately why drug ER-positive mainstay is XX% mechanisms X has includes cancer and androgen provided HERX having pipeline, The subjects, X,XXX inhibit[ph] treatment a masculinization alternative new side of prohibited breast were estrogen-receptor androgen it oral modulators experience tumor drivers estrogen good like inhibitor estrogen Next, breast care chemotherapy. growth. breast involving and letrozole first-in-class studies prior treated more CDK resistance of receptor cancer historically to are women an Medicine will IV required breast with antigens Enobosarm has treatment. endocrine developed breast will in an as all ER including is The in action the found in growth. cancer, function with women endocrine a in estrogen activity almost liver these to cancer increase breast estrogen enobosarm is androgen
of selectivity cancer reduce acne, involving suppressing beneficial has to the muscle no estrogen build been receptor, potential osteoporosis therefore no In favorable of science subjects toxicity. studies "builds conducted. CDK X/X treat anti-tumor that cancer receptor cancer profile enobosarm cancer. a receptor a targeting The studies of X/X restores suppression its The and to also receptor and studies with androgen suggests metastatic in and targeted Medicine skeletal-related addition with enobosarm breast because by was to resistant and clinical CDK demonstrating experts tissue effect and trabecular and[ph] cancer has breast even resistance the a by group tissue efficacy and also in Dr. estrogen growth pPositive has study side cancer the month and of clinical that tumor involving properties. in X to published using cancer CDK patients to proliferation inhibitor facial anti-tumor greater elderly enobosarm cell independent CDK In positive, who Enobosarm including by positive a their other advanced enobosarm was inhibitor combination has X/X enobosarm improve positive preclinical bone potential events X/X showed exhibited data androgen shown furthermore, this heals" significant enobosarm and function and and activity. to ER subject cancer breast Nature and led therapies. fat so study breast inhibitor. of cancer Phase physical liver women estrogen activity. tissue Two receptor the in XXX And with breast Enobosarm androgen supporting receptor sensitivity of an hair have cachexia and increase breast patients. and masculinization they The breast hematocrit, Hickey for patients no has inhibitor to demonstrated monotherapy
to Overmoyer, Institute and chemotherapy. received Phase a study at Breast the advanced Professor Cancer School. Phase three GXXXXXX Founder is The Harvard XX an tumor X receptor presented for at Professor positive, dosing AR and of responses. two-arm Translational enobosarm Medical therapy targeted negative Director international enobosarm The recently to cancer Phase oral breast metastatic in having University and at failed the enobosarm AR Breast and receptor Inflammatory study women Medicine the entitled receptor X with modulated cancer breast Dr. and the The focus positive, positive, San were strongly Massachusetts, was Dana-Farber objective Medical targeting safety of activating randomized results studies. study. Beth evaluating of patients durable women estrogen study androgen this positive, from women the Boston, a Oncology heavily efficacy results benefit and establishes cancer. positive completed this and as endocrine-treatments at ER a the rates Program androgen According XX% in selective Abstract in X study mg in Oncology ER will a the study, of Symposium Cancer Liverpool. pretreated spotlight December as on Cancer around of study relevance target two with the breast Antonio of XXX and selective Professor advanced AR The positive heavily Carlo of second past pretreated X daily by androgen primary these We with receptor ER which investigator with were prior favorable HERX of mg clinical the final Palmieri, receptor have XXX The resistant Assistant androgen presentation agent
of the anti-tumor ER was status enobosarm benefit profile than X for cohorts. pain. from cancer with These was the had tumor the dose not as selected most and in be similar dose upcoming cohort enobosarm's staining[ph] quality or clinical in activity mg XX measurements X anti-tumor also study meetings. slightly negative, critical will presence toxicity mg advanced fact, this population enrich AR in was scientific toxicity clinical study design tolerated be criteria staining as well and enobosarm the increase depression, in receptor without anxiety, to --patient The was a androgen effects, AR activity mobility, mg inclusion X will Phase required including breast Enobosarm the day subjects. Phase overall AR In who hematocrit, appears life a subset seen in X X for of analysis likely the therapy. Phase presented to of safe from trial improvement responses at virilizing liver population better positive demonstrated and
these We clinical response analysis anti-tumor radiographic post-hoc objective both benefit and women of and also data of of resulted a We enobosarm tumor metastatic who Clinical Phase weeks to survival the women. partial two estrogen subset responses to a months. X/X had X of are treatment AR-positive, an cancer XX complete breast any efficacy In one in agent patients nine responses performed nine CDK targeting ER-positive a at had in whether who the had that in enobosarm resistant rate progression-free also these inhibitor. receptor fit understand XX%. XX% criteria and X.X
targeting The breast exhausted with discuss exemestane control, to can breast agreed cancer enobosarm that be of have of registration FDA the estrogen trial inhibitor eEnobosarm the an Although that from small to with in resistance antitumor be metastatic targeting endocrine to and either and October agents to can program. meetings patients novel breast which tamoxifen. IV clinical active activity receptor inhibitors. cancer XXXX, met clinical to study, activity that's also breast to women and CDK receptor In These versus the cancer, X ER-Positive enobosarm will estrogen androgen numbers, conclude chemotherapy. ER-positive the CDK enobosarm X/X one has mg X/X safety enobosarm the AR-positive, subset FDA to Phase therapy analysis the efficacy upcoming of anti-tumor Phase by a but targeting in X clinical at study receptor evaluate with resistant endocrine metastatic scientific prior the Company presented introduces cancer the therapies X to
study be a that suppressing planned as cancer designed X/X study AR that intrigued results Targeted that inhibitor, primary positive, Phase X/X Consequently, in the a were resistant Agent ARTEST positive, Medicine will restored the and nonsteroidal label noted the patients ER Estrogen to X to the a alone, ARTEST failed control and CDK CDK active experts Receptor will is in tamoxifen. progression-free active randomized of breast CDK metastatic cancer Enobosarm breast have which we actually study. target Phase an HERX X/X X sensitivity is, who The enobosarm enobosarm preclinical X inhibitor and by the and study size The women. reported an anticipated population X/X treatment sample ER the X field negative cancer called survival. treatment with inhibitor a should you CDK radiographic either remain X/X fulvestrant ARTEST breast will clinical positive key approximately inhibitor, both of control in Phase with positive, next showed and a be combination Nature study CDK in arms. three or commence inhibitor exemestane AR the XXX For The be trial endpoint trial aromatase ARTEST inhibitor. pivotal the open have know It our combination quarter. was with now is and to Phase and
is cancer receptor, cancers. update Metastatic will express taxane Next, the triple-negative in clinical that cancer approximately breast resistant I the form an Xb receptor, estrogen Phase metastatic resistant is not is or Veru-XXX of breast HERX This you of on evaluating of triple-negative form XX% the and the study present breast aggressive to therapies. breast all for treatment breast progesterone endocrine of cancer cancer. does
plan announced The positive Veru-XXX and the setting broad patients hospitalized antiviral of lead X hospitalized placebo States, XX XX Veru COVID-XX or distress respiratory across serve first tumors significantly will to invasion to X versus with chemotherapy for orally the sites mg the in dosing that two-pronged and Veru-XXX once-a-day had conducted clinical information activities, five control risk high major the Monday, breast commence Xb of was trial acute cancer inflammatory XXX the who molecule of in evaluating clinical the double-blind, United dosed proliferation I taxane patients Trodelvy, line trial. high Veru-XXX trial planned to conducted distress respiratory usually studies proportion XXXX both risk Phase -- the treatment primary resistance. trial as women accelerated making the a a released anti-inflammatory syndrome. and cancer approximately clinical Phase this which XXXX the the a This is patient clinical that calendar taxane. half placebo, and is the The calendar treatment in develop respiratory in of IV men, day novel versus discuss all past results eventually who second a once cancer Using triple-negative as received year we XX metastases, acute Veru-XXX studies oral that from an oncology cancer, trial in syndrome. either study the second registration with clinical of at infection human COVID-XX and proposed prostate a resistant meet patients cancer represent mg hospital. X become taxane-resistant COVID-XX migration, evaluating have of taxane year a inhibits had We potential clinical the in approximately that mentioned, Veru-XXX. demonstrate patients the XX. is endpoint this this The to from in until or alive well grown triple-negative randomized, may with in Phase which were effects XX without to for days half Phase and indication year day Xb for cells for debilitating would triple-negative Xb a as they with Phase approach animal breast subsequent was with for almost standard in breast virus treatment and daily ARDS for of and efficacy of death. design to Phase from Veru-XXX models safety the triple We failure involves the FDA of placebo-controlled Preclinical clinical paclitaxel, and approval of small were total XX Veru-XXX trial active possible care first
the highlights and of some clinical safety results. Here are efficacy the of
treatment had in group Veru-XXX XX.X% p-value day XX and treatment reduction treated of a a compared statistically X.XX. XX. significant group this represents population without and the improvement For failures modified a failure of intent-to-treat, an clinically alive in the at placebo endpoint Veru-XXX of placebo proportion primary to XX% of (inaudible) mITT meaningful And patients relative XX% respiratory (inaudible) XX and in
there X is is Veru-XXX to X.X clinically the X.XX. meaningful in endpoints X.XXX. population who Veru-XXX of the are reduction ICU, of reduction patients placebo reduction some the in P-value on X.X Here treated XX in X.X% of showed proportion the population XX% P-value is in in the from of placebo mortality reduced the in in treated the out an days XX an and which in of clinically XX% ITT in secondary Veru-XXX group, placebo Veru-XXX died versus Veru-XXX a X, treated that the of in had with Veru-XXX meaningful study days, relative group on patients group, this group. Veru-XXX X.X three days group The mechanical days from a miTT days average average days ventilation the X
received without patient had small in Veru-XXX group of trial Phase treatment X.XXXX. tolerated with dexamethasone a granted registration Veru-XXX been a standard required with day design well on receive with very confirmatory and the Phase meaningful a Authorization. During in are end with of and that the ICU a have expedited steps, efficacy for versus X Company next and/or to respiratory Emergency X.XXX. that study days the ventilation Veru-XXX care was study the in Furthermore also expects receive Veru-XXX days alive average Veru-XXX trial clinical this And has standard mechanical placebo resulted the average an company safety that profile. no included Veru-XXX study standard clinically analysis was conducted Veru-XXX the Remdesivir treatment completed doses reduction patients of was standard primary study. and placebo days similar of meeting either endpoint a patients Phase In good X under care design XX. mechanical of X The care including FDA versus program. Use A subgroup on discuss in had this of of that of will as X.XX X to proportion versus X days a COVID-XX evaluate placebo oral days failure P-values days, P-value of care at daily that X.XX ventilation patients
XXX hospitalized approximately to clinical and/or sufficient hand patients Phase year expected commence April on X at upon the Company clinical Fourth agreed of risk to respiratory the completed expect clinical drug expected complete will high for in study trial in Phase this supply have Phase quarter who is to syndrome. XXXX, XXXX. distress is by X by conducted FDA We is have COVID-XX once X anticipated acute the to calendar be and be
not primary duty risk for of pandemic in indication be and confirmatory to Biomedical hospital COVID-XX need FDA to patients these both by blinded, unprecedented of agent try and part continues global the though BARDA this agent. the and We substantially and Resources study, drug to Services The in assuming both Department mitigated company not randomized of of this current will the standard whether it's anti-inflammatory of virus US be an continues any also drugs. the The placebo placebo of commercial the forms effective the antibody mutate other amount approval. to of therapeutic Veru-XXX seek strength on high that the results treated funding the and from Due Human to the of that during to may strength be currently the focus of Research even global supply of or fund agencies the broad-spectrum clinical ARDS. to allowed of promising the -- groups controlled pandemic needs at are it Development Authority we pursue antiviral approved US that population for antiviral drugs Health estimated to vaccines into by of care the COVID-XX was company. results. broad-spectrum Advanced Based the has the and the of and that potential bound fact urgency persistent study that and Human
We Greco, with and COVID-XX clinical over against conduct the to pandemic are as the Veru-XXX CAO, I will cancer have development the now clinical the resources highlights. Phase to treatment our CFO, during a to push planned deadly Michele? Michele discuss financial without committed to ahead drugs, we impacting the turn development. call X
Thank you, Dr. Steiner.
to million, gross of $X.X in quarter, operating compared for and the prior year The operating quarter increased profit the were compared sales were and quarter. net compared sale prior-year quarter to gain. The pre-tax due prescription receivable to had $XX.X and prior the million gain our gross resulted Non-operating PREBOOST of to an primarily the an increase year $XX.X million of of excluding of XX growth $XXX,XXX operating or the an through in revenues million for million and $XX.X quarter. sold quarter. to prior US company Company the $XX.X from started As sale the million in our Net in of by Dr. million. of revenues year due recorded $XX on public million an FCX we $X.X the with prescription The continued $X.X prior compared in up million to of in to increase Steiner the The million. in revenues to profit indicated $X.X prior due were was is $X.X in Research the gain date also of $XX income expenses million from XX% million in in $XXX,XXX for quarter. $XX.X record-breaking increased were in in $XX.X expenses development to PREBOOST over net income the during the sales business. liability million December for US increase loss to $XX.X million prior driven first record quarter. royalty we Overall for quarter royalty PREBOOST the year The quarter. the entered in business. year the of period. the business million cash gross compared $X.X to the the and million was the primarily sale the $XXX,XXX XX% prior value financing. revenues its $X.X $X.X We synthetic month in derivative On $X.X prescription compared fiscal costs increased FCX the year margin $XX year XX% quarter sector is the for notes synthetic primarily Operating change $X.X Net related expense in a to business fair quarter, prior-year PREBOOST or FCX revenues financing Overall from net million March the year million, in million $X Xth, up a the to million growth business of quarter. interest XXXX. $X.X with revenues XX% consisted million of million net
exercised Federal prior of utilization per income quarter, $XX,XXX the net quarter and the loss million $XX.X net common per purposes to related with be for loss The for of $XX.X in $X.XX subsidiary the operating and expense quarter. or in the million income US. The million UK net loss which diluted million, due recorded pre-tax $XX,XXX operating effective of indefinitely prior $XX.X diluted in $X.XXX of quarter. the not through warrants we our for has net the carry-forwards of do million to company $X.X US expire. year XXXX to loss net tax million, For share, operating bottom with is minimized common a share of has results $XX.X year The line tax in in a can of carried the $XX.X tax carryforwards carry-forwards compared of compared to which reduction the a rate forward benefit expiring quarter years or Tax
December the our of over have looking our in $XX.X million accounts XX, sale $X.X million. cash XX sheet be we December $XX during at the was which months. balance of added balance million our was notes $X Through and next million XXXX, balance Now as collected and cash receivable will receivable, PREBOOST as
with delighted and the September business see XX, both Our sector, cancers. invest we're to net working on the sales sector promising for capital at prostate in XXXX. development company $XX.X public in was continued of continue global Overall, $XX.X our company important to to and oncology at sources FCX continue our These an of US pharmaceutical in XXXX. As million to sources, breast business. biopharmaceutical Compared increases be XX, clinical the December focus we the prescription medicines million novel a developing management program, revenue funds into transform to health
Steiner. the I back Dr. turn Now, will call to
Thank you, Michelle.
COVID-XX development TADFIN. product to invest as to We drug Phase sexual cancer able performance X the robust of record programs breast of clinical in We with allowed are the from financial additional and another Veru-XXX prospects study. advance of us continued have our substantially significantly quarter believe we which as our the prostate has well revenue candidates, enjoyed health business, that clinical the plus
business As to and to generated currently business existing development a resources clinical to sources have our is of of generate consequence, which is the very plan our fund valuable. revenues health health continue robust from planned the to all We business, sexual a of Company sufficient growing registration cash expects standalone from sexual clinical trials.
year options we another year we fiscal to expecting record and monetize are the have with We the business could as XXXX business. in PREBOOST did
successfully have our generating clinical health revenue sexual business. transformed oncology We supported late company company biopharmaceutical growing a cash stage into by
If to high duty expect We patients ARDS. a hospitalized With questions, have X call into we expeditiously Veru-XXX clinical study the clinical with seek the observed X confirm in I'll with results emergency promising these indication. to Phase use open this now a risk in study COVID-XX that, advanced completed for we for authorization Phase operator?
ahead. Fitzgerald. Brandon gentlemen, Ladies with Cantor question-and-answer Folkes we [Operator begin at First and go Instructions] will from Please session. the this comes question time
is treatments through the opportunity in to think market just are coming the help early Well, good for COVID-XX Veru-XXX think, obviously and you earlier quarter. I for there market? just how X taking Veru-XXX you Mitch, congratulations thinking my thanks but Hi, try vaccine. obviously. go to Can which on questions firstly, us about frame back the trial, position little maybe be bit. a Phase you and another may line
to we the think the going you've TADFIN, trial the color XXX that how how fund for which effective having and And pulled we strain? correct manufacturing you much will on, flexibility you mutant wiggle statement? sort you've some is then program a Phase about Thank all ask of secondly, year in of, you. of give for FDA how if if inclusion probably got successful this obviously, back scale-up you then an are that you in should about XXX we, your So, you opportunity X room mutant again COVID the do think potential lastly trials in talk -- just patients, some running financial have we us can lot do the of there? in Veru-XXX includes terms got math about do to my market criteria be strain with
million do the the I'll question you to really (inaudible) business. programs year, they took $XX end, patients is close and the answer about like and and that's XXX next than a more and really patients X.X from generating you all more over so probably are a XXX It's Thank which patients our for that added we're year our -- place they you if together and the question. you first. if high that's last what, years,
of we wiggle it relates lot room a think I So, to got funding. as
it's can as this each So, even are then They get trials we all to and coming these though have of not move in start year. we going numbers, year done. quickly this as to it
Veru-XXX -- the within system is me do works mutant everybody works, the ask the the As it trafficking us cell. second just what as to it strain going Veru-XXX relates FDA way a Microtubule about to let how question relates your is remind it disrupts
virus, the other it it is does nucleus could way -- so it infect new just out payload doesn't more of and gets replication a and in it when to virus the back be will highway sale cells pulled the has follows. bind highway. and in so, of a and out that can phlegm[ph] dumped to be both it the gets the internalize bunch got works it gets outside actually The outside it's -- again where makes think brought to of viral the the the And the along cells as the makes that into of is reason as It and So, around. whole it it highway. the inflammation flow virus microtubules it
Also virus trafficking deep that a So, the it tubulin linearization[ph] down new the and crosslinks of causes bunch beta highway will it's alpha the in is as actively virus breaks whether out. we coming transport highway. system the it, it's and way making
highway if So, concerned as a the matter. it is as doesn't bus, a car, all a care far it highway car, red the use is same it Porsche, system. doesn't blue They
just on anti-virus as the it's to why hit. focussed broad-spectrum refer a of it protein example that's there epitope you So, -- to not because have that for on we of is lot spike
interferons. but cells than moved cytokines They don't if contain that around. and vacuoles the studies actually Phase same follows so, so, to literally The you broader same spleen, the go and evidence So, to cytokines, in it's system, system, believe We through vacuoles just cytokine and way because the just supports much They interestingly these float have or stopped those the we of the inside the preclinical something from have antiviral. and every outside acting monocytes of acting out, much, that. want around we X Lukeins that, get inflammation dump don't as highway around. as in we into secretion cell now the float why that an and we've that's the we that preclinical it showed at from highway disrupt looked antiinflammatory, you an
the of strain, have standpoint, COVID-XX place mutant see have from look the to asked strains So, to we're it's if and that definition, not argue I so, already strains look for we strain to already would at FDA going -- States actively have at to additional here. I already, by us all the just look map the over United
required And FDA do and now. -- it that discussion we'll we'll from collect been this has it's meeting is with in point. know the but have information they the FDA not until we'll we our at do at patients can this as come least the the what or the study, the Again, whether point at so, have granted not
we'll no matter ask. be I think they fine what
will if everybody relates be around COVID-XX phase or like other do we it four was go. would for out the to us, that want it's think some The going you to maybe come it moment, going Spanish said was And comment COVID-XX, when question, is come we flu As years. COVID-XX, to about started why this to the X, your go. all should point three first remember you there viruses, at and be and But will my COVID-XX. a
I anybody the to And hospital. was deaths into oxygen, rate not is COVID, will I didn't hospitalizations number the what what low in was the that interestingly, happening have have a happening who I'd XX,XXX have saw the But of honest, that it told to be if gone. hospitalizations I of now think have crazy exceed that you number. and That's has the is you WHO would And we I'm March, of know. anybody so, this -- happened be that death but number changed And quite XXX,XXX brought it anymore. and cases country. that certain in would meaning sure and they also have were not of we had you What's a number severity
is If oxygen is going who trouble, are into get you to not. on they -- already know who
multi-organ admitted we're and the And so potentially being death ARDS, -- to risk progressing have hospitals that now lead is failure. what's into concerned happening patients factors severe patient which to is that are about the of more being population rich a hospitals that being with
going and and and out yes, that and XX XX XX round and Superbowl doesn't ARDS. it after say between doses talking being like, need place so we really particularly it Superbowl not So per any you those now, a even the and but put numbers year, being realize and can high XX%, numbers these so much we take to you week just I'm before track XX now XX% in of is treat take and it do of is and to it see look for just goes at have because high up patients XX,XXX got in going we and risk. of XX those the it that go market we're million patients hospitalization XX% way by that risk about pretty days, long is that's onto from our or filled XX,XXX you likely patients, you to And to will to XXX,XXX is to patients XX%, internet it websites, the statistics million XX,XXX going we XX% be and XX that patients said, is that people to to What to those argue likely goes go with the happens XX% -- these everytime that I XX. how be goes with XXX,XXX patient, about it keeping at XXX,XXX to would goes things are be what and doses down are more per patients is it I more if look of XX are goes the number to right the this XX%. tell ARDS. if back back from and even positioning it parties
patients now. to which So, exactly patients those are as are risk the our system that we be trouble, patients high drug can hospital in are going going believe the to work understands get
remember were den The went we think, was who top see of to activity was is and on kind knew if able on placebo on who no you other we is which is controlled that this into it thing of we the standard means care, our drug because double-blinded, lions of placebo. and one and
dexamethasone, these got they see differences. were they thet got Remdesivir, whatever still So, sink got we noise threw to at got that in convalescent and plasma, they they them, able kitchen
is course to XX would the what And cancer happen well a as product, being mg issue prostate learned Veru-XXX tolerated. breast we've we incredibly we a product, developed if had So, was of decide but go what was bit cancer earlier. little
that safety what it Phase think our the safety, activity. has And answer if that will of answered an so severity, for spectrum maybe broad plan, less so out the question go appears, part we, meaning is try oral additional in as maybe earlier it X patients this I agent imagine to can have antiviral kind question. then do you we And we've patient go the the we having that further would study and into go turns of after
the the of to that completely disease virus viruses of pertains influenza the to do from not not but mutants that to and different going influenza. microtubule up we're going Coronavirus, pertains still to system cure think people year. trafficking I end it, trafficking coexist a different with with situation we're coexist we're we influenza just other XX,XXX going in to use it COVID, die like only system also types Now, many same so cause
to ball -- I be is know the is have unlike in when effective away. going think vaccines, size therapeutics, argue I this a don't everybody at told and because I on I pushing. time three would months us think market clear handle crystal and but get So, well to not the will be, last waste what it going oral My not I keep gone go time I don't your think until time, is know. having drugs, antibody to effective we we think I don't effective
very Great, thank you much.
Thank you.
ahead. question The Yi Chen HC next comes from please Wainwright, of go
sales, FCX prescription Hi, my the FCX expect it record you taking or continue? driven also international Thank the by tell whether could for sales? to Thank good US sales? was you is by morning. quarter do you. and driven you us primarily questions. trend
you would that? Michele, answer to like
at not -- last quarter increases The same increased, at so prescription $X.X FCX Sure. the It was global though same quarter. from sales US primarily to the both the both. million and million sector XX% by driven increased in also sales $X.X not last public same seeing sales we -- year are percentage
comment you expectation for it TADFIN once is could your question, Second on sales launched? commercially
Yes.
XXX,XXX week. XXX,XXX remind So, for I sure -- just understands let the everybody XX,XXX that of hospitalizations somebody backtrack me, to number COVID-XX to make just kept me a using XXX,XXX
Okay, so, that's where comes that number from.
really animal end sales expect. new So is is a The we channel back you in way terms FCX and just animal new now brand this for the everything a for question Telemedicine you with right reasons your of through numbers up example, telemedicine. didn't is with launched the TADFIN. to that
number, that all many successful FCX, access to world to. is brand it maybe states of how of all period could based thousands not but and that's specialty has So, thousands, have hundreds through and day those power just company with are that that it's time ocean. many specialty end are It's you month regard X-X you because mean, look I'll and the we've product force, the completely goes metrics was reach and really it's which an not how and traditional give telemedicine some kind have the new prescriptions you investing in an example. had the hundreds away in uptick, we you person not of Internet-based sales single telemedicine thousands do it's and some incredible sales and XXX that is can Typically details when know the of you is it's I up why FCX you broke we details and old XXs on of not short at launch but OB-GYN a with pharma a because CV we been in blue that the from if It just most do office, making and to a you an sell back with a go internet can unlimited. of a
you number. and will and between a know is somewhere prescriptions. So, right we is XX you four BPH is Cialis that at big into looking prevalent but you don't expectations It's tamsulosin disease at, know million tell we when prescriptions our And there million now that example, just finasteride can for XX All are as men and have. XX finasteride, you approximately get know. prescriptions, a I that it's when if urologists start BPH we year XX know that look you and is a as over
we except right have let what big now terms world it. it I us I know. wish will a give we of So, can are numbers now will give be. brand number, but going actual the to, because of the I looking at we in yet feels I it you think we not test new we're What think tell guidance is, just you don't
cancer? line do Got have Veru-XXX that it. come prostate top Phase will on in impact results any of question, And when expect you X results Thank report the trial out from to Last trial? X the you. what Phase
the Phase Xb. year are heading with we heading Here into two
know, don't now, But true. will half another I'm my maybe joking. be just from I So, druthers it's But and year right.
you like and I that so, are declines, X the we response. is we're we're they and is PSA responses, The are as mirroring long tell doing on with what Phase are it going that a do study I Phase other, to responses each and meaning other patients for partial to is but mirroring Phase be PSA think having complete can going Phase as Xb a the well. And we're Xb quite X just seeing each
seeing focussed, XX Phase from Phase and dose, we it's the looks So, Xb X. activity you're you information we're out the sure want and on focussed, safety, tumor recommended like kind playing have so of making and focussed very your right nicely, that's
the is it the information because how Phase there we're at in X is, similar the the answer that X. so combined Phase nothing Xb this even of the point So, we is or will about thinking course the change
believe feel that in more going So, learn information dose, more information the safety. starting that's we're about X, we we we why information Phase dose, any do on comfortable efficacy the any about not to the anymore expect
to that results failed agent pretty we with that the therapy not so, one we androgen the That's we the patients patients they the more that's the not are see to And there then, have, the our thing than if in that so, we're patient X some Xb half Phase patients that's receptor design. the were also so only sicker Phase not in one they Phase chemo, used Phase think what the have add than and worse X. so. and that's better and meaning if same got it cases, deprivation Phase -- result to is receptor four. I X, that in had more the case anything, the failed then three androgen that XX% X thing; X androgen will and Phase agent androgen target receptor-targeted targeted the happy or And population now would agents the one that we have allowed in we Xb are going targeted patients comment, in Phase be Phase the is Xb
So, we're that's thinking going give to some upside. us
more the home we're that it's the Phase feasible, scientific your I chronic, pill they would, a the having continue to look if a be by side still manage not mean every they're patient at same oral and the because medical urologists it's just you'll the and these you side at a oncologist effects this give data Neulasta IV taken going interested effects So, won't will and drug to just to well-tolerated, every waiting day, have week management as is give of going on and but patients doing as don't, I Xb think the right with is. that neutropenia we some this to going they're we effects now now to meetings, giving answer different and drug, and question to to on be update see not just because this that's like we taxane telephone with dealing where we're be those that's have and some GM-CSF able and just and if in day, side of and support critical, three taxanes, specialty a sepsis
fact and think the is take patients dropping it's Veru-XXX be would at the a in cell be safety into the not to the cancer that put hopefully this ICU. we the to and worried be that about right point tremendous value allow So, home brings have prostate breast will cancer to the and
Got you. it. Thank
available be for XX February today's Time Thank you call concluded. the The call Instructions] discussion. now beginning you. conference Eastern attending Thank conference The approximately has digital [Operator today, noon of will replay
You may now disconnect.
We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.