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VTUS SEC Filing Form 8-K
 

VTUS SEC Filing Form 8-K

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FORM 8-K. Filed 05/07/12 for the Period Ending 05/07/12. A PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37th Annual Deutsche Bank Health Care Conference in Boston, MA on ...

FORM 8-K. Filed 05/07/12 for the Period Ending 05/07/12. A PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37th Annual Deutsche Bank Health Care Conference in Boston, MA on Monday, May 7, 2012.

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    VTUS SEC Filing Form 8-K VTUS SEC Filing Form 8-K Document Transcript

    • VENTRUS BIOSCIENCES INC FORM 8-K (Current report filing)Filed 05/07/12 for the Period Ending 05/07/12 Address 99 HUDSON STREET 5TH FLOOR NEW YORK, NY 10013Telephone (212) 554-4388 CIK 0001426800 Symbol VTUS SIC Code 2834 - Pharmaceutical Preparations Industry Biotechnology & Drugs Sector Healthcare http://www.edgar-online.com © Copyright 2012, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
    • UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2012 VENTRUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 001-35005 20-8729264 (State or other jurisdiction of incorporation) (Commission File (IRS Employer ID Number) Number) 99 Hudson Street, 5 th Floor, New York, New York 10013 (Address of principal executive offices) (Zip Code)Registrant’s telephone number, including area code (646) 706-5208Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of thefollowing provisions: Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
    • Item 8.01. Other Events. Attached hereto as Exhibit 99.1 is a PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37 th Annual Deutsche BankHealth Care Conference in Boston, Massachusetts, on Monday, May 7, 2012, and which is incorporated herein by reference.Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Slide presentation of May 7, 2012, to be presented at the 37 th Annual Deutsche Bank Health Care Conference.
    • SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by theundersigned hereunto duly authorized. VENTRUS BIOSCIENCES, INC.Date: May 7, 2012 /s/ David J. Barrett David J. Barrett, Chief Financial Officer
    • Exhibit 99.1Ru sse ll H. El li so n, M D, MSc C h ie f Ex ec u ti ve Offic er a n d Ch a irma n of th e Bo a rd
    • 1 Th is mat eri al co n ta in s est ima te s a n d forwa rd - lo o ki n g sta te men t s. T h e wo rd s “be li ev e, ” “ may , ” “ mig h t, ” “ wi ll , ” “aim , ” “ est ima te , ” “ co nt in u e, ” “ wo u ld , ” “ an ti ci pa te , ”“ in te nd , ” “ ex pe ct , ” “ pl an ” an d sim il ar wo rd s a re i nt en d ed to i de n ti fy est ima te s a n d forwa rd - lo o ki n g sta te men t s. Ou r e st ima te s a nd fo rward - lo o ki n g sta te men t s a re ma in l y b ase d on ou r c urre nt e xp e ct at io n s a nd e st ima te s o f fu tu re ev en ts an d t ren d s, wh i ch a ffe ct o r mi g ht a ffe ct o u r b usi n esse s a n d op e ra ti o ns . Al th o u gh we b el ie v e t h at t he se est im ate s a n d forwa rd - lo o ki n g sta te men t s a re b as ed u p on re aso n ab l e a ssu mp ti o ns, t he y a re su b je ct t o man y ri sk s a nd u n ce rta in ti es an d a re ma d e i n l ig h t of in forma ti o n cu rren tl y av a il ab le t o u s. Ou r e sti ma te s a nd fo rward - lo o ki n g sta te men t s ma y b e in flu en c ed b y t he fo ll owi n g fac to rs, amo n g o th ers : ri sk s rel at ed to t he c os ts, t imi ng , reg u la to ry rev i ew a n d re su lt s o f o u r st ud i es an d cl in i ca l t ria ls; o u r ab i li ty t o o b ta in FDA ap p ro v al o f o u r p ro d u ct ca n di d at es; d iffere n ces b et ween hi st ori cal s tu d ie s o n wh ic h we h a ve b as ed o u r p la nn e d cl in ic al t rial s an d ac tu al re sul t s from o ur tri als ; ou r a nt ic ip a te d ca pi ta l ex p en d it ure s, ou r e sti mat es reg ard i ng o u r c ap it al req u ire men t s, a n d o ur n e ed fo r fu tu re cap i ta l; o u r li q ui d it y an d wo rki n g ca pi ta l req u irem en ts; o u r ex p ec ta ti o ns reg ard in g o u r rev en u es , e xp e ns es an d o th er re su lt s o f o p erat io n s; th e u n pre di ct ab i li ty o f t he si ze o f t he ma rke ts fo r, an d ma rk e t acc ep t an ce o f, a n y o f ou r p ro du c ts, i nc lu d in g VE N 3 09 ; o u r ab il it y t o sel l an y a pp ro ve d p rod u ct s a n d th e p ri ce we are ab l e re al iz e; o u r n eed to o b ta in a d di ti o na l fu n d in g t o d ev el op ou r p ro du c ts, an d o u r ab i li ty t o o b ta in fu tu re fun d in g o n a cce p ta bl e te rm s; ou r a b il it y to re ta in a n d hi re ne ce ssary e mp lo y ee s a nd to st aff o u r o p erat io n s a p pro p ri at el y ; ou r a bi l it y to c o mp ete i n o ur in d us try a nd i n no v at io n b y o u r co mp e ti to rs; ou r a b il it y to s ta y ab rea st of an d co mp l y wit h n ew o r m od i fi ed la ws an d re gu l at io n s t ha t cu rren tl y ap p ly or be co me ap p li ca b le to ou r b u sin e ss; est im at es a n d est im at e m eth o d o lo g ies u sed i n p rep ari ng ou r fi na n ci al st ate me nt s; th e fut u re t rad in g p ric es o f o ur c o mmo n st oc k an d t he i mp ac t of s ecu ri ti es an al y sts ’ re p ort s o n t he se pri ce s; an d t he ris ks set o u t in o u rfi li n gs wit h t he SEC , in c lu d in g o u r Ann u al R ep o rt on Fo rm 10 - K. E sti mat es an d fo rwa rd - lo o ki n g sta te men t s i nv o lv e risk s an d u n cert ai nt i es a n d are n ot g u ara nt ee s o f fu tu re pe rfo rma nc e. As a re su lt o f k no wn a nd un k n own ri sk s a nd u n ce rta in ti es , i n cl ud i ng t h os e d e scri be d ab o v e, th e est im at es an d forwa rd - lo o ki n g sta te men t s d is cu ssed in t hi s mat eria l mig h t n ot o cc u r an d o u r fut u re re su lt s an d o u r p erfo rman ce mi g ht d iffe r mat eri al ly fro m t h ose e xp re ssed i n t he se fo rward - lo o ki n g sta te men t s d u e t o , i n cl ud i ng , b ut n o t li mit ed to , th e fact o rs me nt io n ed a b ov e . E sti mat es an d fo rward - lo o ki n g sta te men t s sp ea k o n ly a s o f t he d at e th ey were mad e , a n d, ex c ep t to t h e e x te nt re qu i re d b y la w, we u n d erta k e n o o b li g at io n to up d at e or to re vi ew an y es ti mat e an d/ o r fo rwa rd - lo o ki n g sta te men t b ec au se o f ne w i n fo rma ti on , fut u re e v en ts o r ot h er fa ct ors. Fo rward Lo o k in g St at eme nt s
    • » A Ph ase III b io p ha rmac eu ti ca l co mp an y fo cu se d ex cl u siv el y o n g ast ro en te ro l o gy ; sp ec ifi ca ll y, a na l di so rde rs - a n e gl ec te d area o f d ru g de v el op me nt » De v el op me nt ri sk st ra ti fie d ac ross th ree l at e - sta ge p ro du ct s NC E an d 5 0 5(b )2 reg is trat io n p a th way s Two p iv o ta l Pha se III re ad - ou t s fo r two s ep arat e p ro d u ct s e xp e cte d i n 2Q 2 01 2 Poss ib le v al id a ti on o f t wo l ead pro g ra ms Ra ng e o f co - pro mo ti o n/ p artn e rsh i p o pp o rtu n it ie s c ou l d fol lo w da ta » Pro d u ct s a dd ress la rge , un d erse rve d , a n d un t ap p ed ma rke ts 3 of th e to p 1 0 GI d is ord ers Sig n ific an t ma rk e t p o te n ti al s i n sp ec ia lt y p ha rma an d p ri ma ry care » Wel l fu n d ed t h ro u g h ke y mi le sto n es Ca sh an d c ash e q ui v al en ts of $ 3 6. 9 M il (Dec 3 1 , 2 0 1 1) $ 20 m m IPO (wi th o v eral lo c at io n ) i n Dec 2 0 10 ; $ 5 0 mm fo ll o w - on i n Ju ly 20 1 1 2 C o mpa n y Ov erv ie w
    • Pip el in e 3 Pro gra m (Pat h way ) In di ca ti o n Cl in i ca l Pha se Pot en t ia l NDA Fil in g C o mmerc ia l Ri gh t s I II III VE N 3 09 Ife ran seri n ( NC E ) He mo rrh o i ds 2 01 4 Wo rld Wid e , Un p art ne red VEN 3 07 Di lt ia ze m (5 0 5(b )2 ) An al Fi ssu res 20 1 3 No rt h Ame rica , Un p artn ere d VEN 30 8 (5 05 (b )2) Fec al Inc o nt in e nc e 20 1 5 No rth Ame ric a , Un p artn e re d La te St ag e Pip el in e wit h Two Piv o ta l Ph a se III R e ad - ou t s Ex p ec te d in 2Q 20 1 2 fo r Val id at io n o f T wo Lea d Pro gra ms
    • VE N 3 0 9: Ifera ns erin NC E for Hemo rrho i ds
    • 5 Hemo rrho i ds : A La rg e , Un d erse rv e d M ark et » 10 ,0 0 0 co n su mer su rv e ye d , 1 ,1 2 5 rep o rt su ffe ri n g fro m h emo rrho i ds 1 : Past t wo ye ars 11 . 0% 2 5 .8 mi ll io n 2 Past y ea r 9 .3 % 21 . 7 mil li o n 2 Da y o f su rv ey 2 .9 % 6 .7 mi ll io n 2 » Cu rren t trea tm en t op t io n s: In v asi v e pro ce du res : ba nd i ng , sc le ro si n g ag en t s, s urg ery fo r p ro lap se d h emo rrho i ds Rx : No FDA a pp ro ve d R x d ru g s 4+ mil li o n p re scri p ti on s of no n - ap pro v ed a n d no n - DE SI i nt ra - an al st ero id s 3 Mi n ima l to n o rei mb u rs eme nt ; No o th er kn o wn d ru g s in d ev . in US, E U* or Jap an OT C: 2 0 - 22 m il li on 3 , 4 OTC u n it s so l d an n ua ll y i n US (e. g. , Pre p arat io n H ®) 85 % rep o rted us in g OTC o r R x tre at men t at l ea st on c e (8 6 % OTC /1 4 % Rx )^ 1 0% o f a ll p at ie nt s re p ort ed h av i ng an i nv a siv e p ro c ed u re (6 1 % s urg ery ) wi th 7 5 % rep o rt in g re cu rre n ce o f sy mp to ms afte r su rg ery ^ 3. IM S 2 0 03 4. IM S 2 0 09 * Ora l Dafl on h a s a h emo rrho i d in d ic at io n i n Fran ce ^ PB E surv ey of 10 ,2 0 2 c on su me rs 2 01 1 1 . Prin ce to n B ran d Ec o no me tri cs S urv ey 2 0 1 1. 2 : ca lc ul at ed fro m t h e 20 1 0 US Ad u lt p o pu l at io n – 23 4 ,5 6 4, 0 00 (2 0 1 0 US ce n su s )
    • 6 Phy si o lo g y o f Hemo rrh oi d s In crea sed in tra - pe lv ic p ress ure Dil at at io n o f t h e h e morrh o id al p le x us , i n crea sed p res su re , swel li ng L o cal s ero to n in (5 HT) re lea se 5 HT2 a re ce pt o r ac ti v at io n Effere nt v en o u s c on st ric ti on & p la te le t ag g re g at io n In te rn a l he mo rrh o id E x tern al h e mo rrh o id VE N 3 0 9 Prima ry Sy mp to ms: B le ed in g , It ch i ng & Pa in
    • 7 VEN 3 0 9 ( i fe ran seri n ) Su mma ry To p ic al rec ta l o i nt me nt a pp l ie d in t ra - an al ly B ID x 2 we ek s (wi th p ro p ri et ary si n g le - use a pp l ic at or) M e ch an i sm o f Ac ti on » Sele ct iv e 5 HT2 a an ta g on i st » Do e s n o t cro ss t h e b l oo d b rai n b arrie r ex c ep t at d os es muc h h ig h er t h an t o b e use d t he rap eu ti ca ll y Prec li n ic al Safe ty » Syst em ic ex p o su re i s < 10 % » Th erap e ut ic rat io is > 1 7 x Cl in i ca l Ph a rm ac ol o gy » Me ta b ol iz ed b y C YP2 D6 in l iv e r » No acc u mu la ti on o f t h e dru g o n twi ce d ai ly do si ng Cl in i cal Da ta » Sev en c li n ica l tri al s i n 3 59 s ub j ec ts (2 2 0 ex p o su re s) » No SAEs, li mi ted AEs (ma in l y GI), si mi lar AE p ro fil e v s. p la ce bo » Sig n ific an t im pro v eme n ts in sy mp t oms rel at ed t o h emo rrho i d s i nc lu d in g b le ed i ng , p ai n an d i tch i n g
    • 8 Effic acy Pha se IIb (Ge rman s tu d y 1 ) 12 1 p at ie n ts ra n do mi ze d to VE N 3 0 9 ( ife ran seri n ) B ID v s. p l ac eb o o in tm en t x 1 4 da y s Wee kl y v isi t s fo r 2 wee k tre at men t ; fo l lo w - up a t 45 da y s Sym pt o ms rec o rde d in d a il y d ia ri es (sca le o f 1 - 10 ; 1 = no s ym pt o ms) Stat i sti ca ll y sig n ifi ca nt i mp rov e men t in s ym pt o ms: b le ed in g , i t ch in g , p a in 1 2 3 4 5 6 7 M e a n ( B l e e d ) 0 1 2 3 4 5 6 7 8 9 10 1 1 12 1 3 14 Day VEN 3 09 PL ACE BO M ean (B l eed ) Pri mary e n dp o in t B LEE DING (n=1 1 1 p at ie n ts) P < 0 .0 5 1 . Hero ld A, Di et ri ch J , Ai tc h iso n R . In t ra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 . p<0 .0 0 0 1 p < 0 . 00 7 5
    • 9 1 2 3 4 5 6 7 M e a n ( P a i n ) 0 1 2 3 4 5 6 7 8 9 10 1 1 1 2 1 3 14 Day E ffi ca cy Ph as e IIb (Germa n st ud y 1 ) Sec on d ary e nd p o in t s: ra p id , sus ta in ed e ffect 1 2 3 4 5 6 7 M e a n ( I t c h ) 0 1 2 3 4 5 6 7 8 9 1 01 1 1 21 3 1 4 Day * = P < 0 .0 5 * ITC HING (n =60 pa ti en t s) PAIN (n =40 pa ti en t s) P < 0. 0 5 DAY 7 P < 0 .0 0 08 ; DAY 1 4 P < 0 .0 2 * M e an (Itc h) Me an (Pa in ) VE N 3 09 PLAC EB O 1 . He rol d A, Die tric h J, Ait ch i so n R. In tra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 .
    • 10 M o d el in g o f Ph ase IIb 1 Da ta for Pha se III En d po i nt s * Ab se n ce o f sy mp to m Da y 7 t hro u g h Day 1 4 M aj o rit y o f resp o nd e rs in th e trea tm en t arm re sp on d b y Da y 3 * Po st ho c » Seco n d ary En d p o in ts It ch i ng : 59 % v s. 32 % p<0 .0 3 4 Pain : 50 % v s. 18 % p<0 .0 3 2 5 7 % 20 % 0 % 10 % 2 0 % 30 % 4 0% 5 0 % 6 0% Ifera nse rin Pl ac eb o P = ≤ 0 . 00 0 1 PR IM AR Y E NDP OINT : No Bl ee di n g fro m Day 7 t o Da y 14 (2 n d wee k o f Tre at men t) Re sp on se 1 . Hero ld A, Die tri ch J, Ai tc hi so n R . In tra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 .
    • Ro b us t, Disc ip l in ed P ha se III Tria l En dp o in t s M ea n in g ful i mp ro v em en t (p ro p ose d b y FDA) • Pri mary en dp o in t : ce ssat io n o f b le ed i ng d a y 7 – 14 (>9 9 % po we re d ) • Seco n d ary e nd p o in ts : c ess at io n o f p ai n, i tc hi n g da y 7 – 14 (>9 5 % po we re d ) Desi g n Th ree arms : • 7 da y / 1 4 d ay / p la ce bo • 20 0 p ts p er a rm • Op e n la b el ex t en sio n t o 1 y ea r to trea t recu rren ce Si te s 7 0 US sit es Inc lu si on crit eri a M e an in g fu l s ym pt o ms ( b l ee di n g, i tc hi n g, p ai n fo r 2 d ay s ) to c le arly de mo n strat e th era p eu ti c effec t Pro g ress • Di sc uss io n wit h FDA o n a ll ma jo r e le men t s o f t he p rot o co l • En ro l li ng co rre ct p at ie n ts • Co n ti nu o u s d at a rev ie w (b li nd ) • Mi n ima l lo ss of ke y o ut co me d at a • En ro l lme n t c o mp le te en d Ap ril 2 0 12 • Re po rti n g o f resu lt s e x pe ct ed l at e Ju ne / e arly J ul y 2 0 12 1 1
    • 12 De v el op me nt Pl an : Nex t Ste p s C h ro n ic re pe at ed u se p rod u ct (FDA d e fi n it io n , m ay n o t ap p ly i n Jap a n/ EU) » 1, 50 0 su b je ct s n e ed ed fo r c omp l et e safet y p rofi le (US a nd po ssi b ly E U) 7 cl in ic al t ri al s i n 3 5 9 su bj ec ts (22 0 e x po su res) 60 0 p at ie n ts in Ph as e III st u dy de sig n ed to p ro vi d e p ro gra m v al i da ti on Seco n d p iv o ta l Pha se III tri al p la nn e d (an d d ou b le b li n d Ph ase III rec urren c e t ria l to d e termi n e safet y /e ffi ca cy a n d tre atm en t for re cu rren ce fo r th e US) – wi ll g e ne rat e a p ro gra m t ot al o f > 15 0 0 p ts ex p o sed t o d ru g » Cl in ic al p h arma co lo g y p rog ram in c lu d in g : DDI , PK in p o o r me tab o l ize rs ( re su lt s e xp e ct ed Q2 ), QT a n d sp ec ial p o p ul at io n s » Pre cl in i cal : Ch ro n ic To x a nd C a rc in o g en ic it y st ud i es (t wo sp ec ie s fo r 2 y rs) » Ca rc in o g en ic it y i s cri ti ca l pa th fo r NDA, cl in i ca l t ria ls ca n b e d o n e s eria ll y
    • 13 Pa ti en t /Pres crib e r Re sp on se t o VEN 3 0 9 1 » Stro ng wi ll i ng n ess to ask t he ir do c to r fo r VEN 3 0 9 a t t h e ne x t v i sit For p a ti en ts wh o are h av in g sy mp t om s n o w , (e st ima te d at 6 .7 m m) 80 % wo ul d * req u est a p re scri p ti on In t h e who l e sa mp le : 66 % rec ei vi n g a pre scri pt io n wo u ld fi ll t he R x at a $ 3 5 ou t - of - po ck e t co - pa y * 78 % wit h h o use h ol d i nc o me a b ov e $ 5 0k / ye ar wo u ld fi ll t h e R x a t a $ 3 5 co p ay * » He al th care p rov i de rs sh o wed h i gh wi ll i ng n ess to pre scrib e an d m in ima l co - pa y p ri ce se n sit iv i ty Pro b ab i li ty o f HC Ps t o g ran t a pa ti en t R x re q ue st ran g ed fro m . 88 - .92 * 1 . Prin ce to n B ran d Ec on o me tric s Su rv ey 2 0 1 1. * PB E fa ct o re d
    • VE N 3 0 7: Di lt ia ze m C rea m No v el Trea tm en t for An a l Fissu res
    • 15 An a l Fi ssu res: C au se a nd M a na g eme nt In cre ase d sp hi n ct er t o ne L oc al i sch em ia Te ar (fis sure ) in an al c an al C au se Sev e re p ai n o n d efec at io n T re at men t o p ti on s Co n tro l co n sti p at io n , t o pi ca l ste roi d s R ed u ce sp h in ct er t o ne C o mp ou n d ed T op i cal d ru gs : • GT N* • di lt ia ze m B o to x Su rge ry Sp hi n ct ers (mu sc le s) An al fis sure 1 .1 mm o ffi ce v is it s/y e ar An al fi stu la * R e cti v (to p ic al GT N) rece n tl y ap p rov e d by FDA b u t n o t y et la u nc h ed
    • 16 VE N 3 0 7 ( d il ti az em ) Su mmary 2 % t op i cal d i lt ia zem cre am ap p li ed p eri - an al ly T ID M ec ha n ism o f Act io n » Ca lc iu m c h an n el b lo ck e r Re la xe s t h e i n te rn a l a n al sp h in ct er, red u ci ng pa in a n d in cre asi n g ti ssu e bl o od fl o w Prec li ni ca l Safet y » Pre cl in i cal t o pi ca l safet y wi th 2 % d il ti az em twi ce d ai ly fo r n in e ty d a ys C li ni ca l Pha rmac ol o gy » To pi ca l ha s < 1 0% sy st emi c ex p o sure as o ral d os e b u t sig n ifi ca nt ly gre at er e ffe ct o n sp h in ct er to n e – i.e ., b lo o d le v el s d o n ot p red i ct ac ti v it y. L ow ex p os ure = b e tt er t o lera b il it y th an ora l di lt ia ze m C li n ic al Dat a » Ten c li n ic al tri al s i n 4 53 in d iv id u al s » In freq u en t mil d AEs rep o rted » Simi la r o r b et te r red uc ti o n in p a in , sig n ifi ca nt ly be tt er t o le rab il it y th a n GTN
    • 17 Pi v ot al Ph a se III T ri al » FDA (an al g esi a d i vi si on ) p re - IND mee ti ng co n du ct ed in Au g us t 2 0 0 7 Ac h ie ve d cl ari ty o n p rim ary en d p oi n t: red u ct io n i n p ai n Co n fi rmed safet y d at ab as e a n d to x req u ire men t NDA fil in g p o ssib l e 2 0 1 3 » Pha se III tria l co n du c te d by SLA (E x - NA li ce ns or) 3 arms, 1 55 pt s p e r arm: 2 % 4 % d i lt ia ze m TID , a n d pl ac eb o i n 3 1 sit es in E u ro p e Pri mary en dp o in t : re d uc ti o n in p a in o n d efe cat i on u si n g a va li d ate d sc al e ( Lik e rt , NR S) Ve n tru s re vi ew of bl in d ed d a ta an d st u dy op e ra ti o ns 1 0/ 2 01 1 : Co rrec t pa ti en t s e nro ll ed , d at a c o mp li an ce an d GC R P are g o od , d at a a re b e in g rev i ewed co n ti nu o u sly En ro l lme n t c o mp le ted ; d at a re ad o u t ex pe ct ed i n M ay 20 1 2 » Plan n ed Seco n d Ph ase III t ri al (s): De v el op i ng 4 po ssi b le ex t en d ed re le ase formu l at io n s: may te st som e o r a ll i n h um an ma no me try t ria l in 2 0 12 . Nex t p h ase co u ld be 2 PH III t ria ls wit h ex t en d ed rel ea se formu l at io n if on e i s ac ce p ta bl e, o r 1 wi th o rig i na l fo rmu la ti o n
    • 18 C o mp et it iv e Trea tm en ts for An a l Fissu re 1 C ro ss, KLR . , et al ., (2 00 8 ) Th e M an ag e men t o f An al Fis su re : ACPGB I Po si ti on St at em en t . C o lo rec ta l Dise ase , 1 0 (Su p pl . 3 ), 1 - 7. 2 M ad o ff , RD. , & Fl esh ma n , J W . (2 00 3 ) AGA T ech n i cal R ev i ew o n t h e Di ag n o sis an d C are o f Pat ie nt s Wit h An al Fis su re . Gast ro en te rol o gy , 1 24 , 2 35 – 24 5 Di lt ia zem i s t he rec o mmen d ed fi rst - li ne t re at men t fo r an a l fi ssu res amo n g GIs a nd C R S Th e l au n ch o f R ec ti v ™ c o ul d a ll ow co st effec ti v e t arg et in g o f p resc rib ers an d i nc rea se AF awa ren ess Wi th o u r AE ad v an ta ge , VEN 3 0 7 co u ld ra p id ly est ab li sh ma rke t do mi n an ce o n ce la u nc he d R ec ti v ™ 0 . 4% GT N o in tm en t BID (T op i ca l Ni tro g ly c erin e ) App ro v ed i n th e US fo r mo d erat e an d se ve re pa in o f c h ro n ic a na l fissu re, l au n ch ed M a rc h 2 0 12 Pri ce d at $ 7 30 WAC p er 8 we ek c ou rse Ex t en siv e l it erat u re rep o rti n g imp ro ve d p ai n b ut d i ffi cu lt si d e effec t p ro fil e: h ig h rat e of he ad a ch es (6 4 % o f p at ie nt s, oft en se v ere), flu sh in g , na u sea a nd d i zz in ess M ed i cal a sso ci at io n s ’ gu i de li n es h a ve c on si ste n tl y d irec te d p hy si ci an s to t o pi ca l di lt ia ze m o v er GT N a s 1 st li n e t h erap y 1 , 2 C al ci um Ch a nn e l Bl oc k ers C o mp o un d ed n i fe d ip in e i s u sed t o a le sse r ex t en t th an d i lt ia ze m Le ss li te ra tu re av ai la b le B ot o x Out o f p o ck et c o st fo r p a ti en ts Su rg e ry Forc ib le d i la tat i on a n d sp hi n ct ero to my M o st o ft en cu rat iv e, b u t fe ca l i n co n ti ne n ce is a p ro b le m
    • Bu si ne ss Ov e rv i ew, M il est o ne s
    • 20 T arg et M ark et s Pro v id e Op ti mal St ra te g ic Fl ex ib i li ty » Spe ci al ty sa le s fo rce a nd DT C ca n b e h i gh l y effec ti v e Di lt i aze m i s t h e re co mme n de d first - li ne t re at men t i n foc u sed ma rke t o f sp eci al is ts 50 % o f cu rren t h emo rrho i d scri pt s (4 m il li on ) a re c o nc en t ra te d in 21 ,0 0 0 p resc ri b ers No da ta t o su pp o rt th e us e o f i n tra an al st ero i ds as effec ti v e t rea tme nt ; n ot a pp ro v ed Di rec t To C on su me r (DTC ) ad v ert isi n g co u ld b e h ig h ly i mp ac tfu l fo r VE N 3 0 9 1 » Partn e rsh i ps We in te n d to se ek a ma rke ti n g p artn e r for VEN 3 0 9 for ex - US te rri t ori es Co - pro mo ti o n op p o rtu n it ie s ex i st for bro ad e r PCP co v erag e o f VEN 30 9 » Pri ci n g an d R ei mb urse men t VE N 3 0 9: No o t he r d rug s in c la ss o r i n di ca ti on : M ed i ca re Pa rt D an d ma na g ed c are imp l ic at io n s VE N 3 0 7: Pa rit y p ri ci n g to R ec ti v ® ($ 73 0 t wo mo nt h su p pl y ) i s p o ssib l e; Ex p ec t maj or sh are of ex ist in g c o mpo u n de d R x, n ew Re ct iv ™ p at ie n ts, p lu s ad d it io n al p at ie nt s 1 : Pri n ce to n B ra n d Ec on o met ric s fo rec ast mo d el 2 0 12
    • Ri gh t s a nd Ex cl usi v it y R ig h ts » Ve n tru s h as al l rig h ts an d t it le , W orl d - wi d e, p ay in g ro y al ti es be twe en 1 % an d 4 % M ark et a nd Dat a E xc lu si v it y » Ne w c on c en tra ti on ra n ge p at en t fil ed wi th USPT O & PTC (Au g ust 2 0 1 0) » Co mp o sit io n o f ma tt er e x pi res Aug u st 2 01 5 » 5 ye ars an d 1 0 y ea rs o f d at a e x cl usi v it y in th e US u n de r Hat ch - Wax ma n Act an d E U, re sp ect iv e ly » To pi ca l GI Prod u ct wi th l o w b io av a il ab il it y 2 1 VEN 30 9 VE N 3 07 Ri gh t s » No rt h Ameri can ri g ht s p a y in g mi d to u p p er si n gl e d ig it ro y al ti es Ma rke t an d Dat a Ex cl u siv i ty » Me th o d o f u se pa te n t e x pi res Feb 2 0 1 8; a pp ro x. 1 6 mo n th s HW e xt en si on » To pi ca l GI p ro d u ct ; s ys te mic l ev el s d o n o t pre di ct a ct iv it y » Ex te nd e d re le ase fo rmu la ti on s (B ID) u n de r d ev el o pm en t to e xt en d e x clu si v it y
    • 22 E xp e ct ed M i le sto n es H1 20 1 2 H2 2 0 12 » PH 3 en ro ll men t c omp l et io n » Re sul t s from PH 3 t ria l (e x pe ct ed J un e) » Cl in ic al p h arma co lo g y resu l ts » Pub l ic ati o n o f p re cl in i cal p h arma co lo g y » FDA mee ti n g » Re cu rre n ce d at a re ad - ou t s from 1 st p iv o tal » Lau n ch s eco n d p iv o ta l an d rec urre nc e tria l » Da ta p u b li cat io n /p res en ta ti o n » Pate n t offic e ac ti on VEN 3 0 9 VEN 3 0 7 » Da ta re ad - ou t from first p iv o ta l PH 3 t ri al (e xp e ct ed i n M ay ) » Go / no go d e ci sio n a nd sel ect i on o f e x te nd ed re le ase fo rmu la ti on » FDA mee ti n g » Lau n ch o f se co n d p iv o ta l » Re sul t s o f n ew fo rmu la ti o n » Da ta p u b li cat io n /p res en ta ti o n
    • 23 Fi n an ci al s » Na sd aq (IPO 2 0 1 1): VTUS » Ca sh b al an ce Ca sh an d c ash e q ui v al en ts YE 2 0 1 1 * $ 3 6 .9 M il » Sto ck d a ta Ful ly di lu t ed sh are s o u tst an d in g 1 5 .3 M i l Sha res ou t sta nd i ng 12 .4 Mi l * In clu d es $ 12 . 5 mil p ay me n t fo r ri gh t s fo r VEN 30 9 t o Amer & C o .
    • » De v el op me nt ri sk st ra ti fie d ac ross th ree l at e - sta ge p ro du ct s NC E an d 5 0 5(b )2 reg is trat io n p a th way s Two p iv o ta l Pha se III re ad - ou t s fo r two s ep arat e p ro d u ct s e xp e cte d i n 2Q 2 01 2 Poss ib le v al id a ti on o f t wo l ead pro g ra ms Ra ng e o f co - pro mo ti o n/ p artn e rsh i p o pp o rtu n it ie s c ou l d fol lo w da ta » Pro d u ct s a dd ress la rge , un d erse rve d , a n d un t ap p ed ma rke ts 3 of th e to p 1 0 GI d is ord ers Sig n ific an t ma rk e t p o te n ti al s i n sp ec ia lt y p ha rma an d p ri ma ry care » Wel l fu n d ed t h ro u g h ke y mi le sto n es Ca sh an d c ash e q ui v al en ts of $ 3 7 mm (De c. 3 1, 2 0 11 ) $20 m m IPO (wi th o v eral lo c at io n ) i n Dec 2 0 10 ; $ 5 0 mm fo ll o w - on i n Ju ly 20 1 1 2 4 C on c lu sio n
    • Ru sse ll H. El li so n, M D, MSc C h ie f Ex ec u ti ve Offic er a n d Ch a irma n of th e Bo a rd