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 FLOORNEW YORK, NY 10013

Telephone (212) 554-4388CIK 0001426800

Symbol VTUSSIC Code 2834 - Pharmaceutical Preparations

Industry Biotechnology & DrugsSector Healthcare

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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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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

Number) (IRS Employer ID 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) 706-5208

� 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 Bank Health 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 the

undersigned hereunto duly authorized.

VENTRUS BIOSCIENCES, INC. Date: May 7, 2012 /s/ David J. Barrett David J. Barrett, Chief Financial Officer

Exhibit 99.1

Russe ll H. El li son, MD, MSc Chie f Exec uti ve Offic er a nd Cha irma n of the Boa rd

1 This material conta ins est ima te s a nd forwa rd - looking sta te ments. T he words “be lieve, ” “ may, ” “ might, ” “ wi ll , ” “aim , ” “ est ima te , ” “ cont inue, ” “ would, ” “ anti cipa te , ”“ inte nd, ” “ expe ct , ” “ plan ” and sim ilar words a re intended to ide nti fy est ima te s a nd forwa rd - looking sta te ments. Our e st ima te s a nd forward - looking sta te ments a re ma inly base d on our c urre nt e xpe ctat ions a nd e st ima te s of future events and t rends, which a ffe ct or might a ffe ct our businesses a nd ope ra tions . Al though we bel ie ve that the se est im ate s a nd forwa rd - looking sta te ments a re bas ed upon re asonable a ssumptions, the y a re subje ct to many ri sks a nd unce rta inties and a re ma de in l ight of informa tion currentl y ava ilable to us. Our e stima te s a nd forward - looking sta te ments ma y be influenced by the fo llowing fac tors, among others : ri sks related to the c os ts, t iming, regula tory review a nd re sults of our studies and cl in ica l t ria ls; our abili ty to obta in FDA approval of our product ca ndidates; d iffere nces between histori cal s tudie s on whic h we ha ve bas ed our pla nne d cl in ic al t rial s and ac tual re sul ts from our trials ; our a nt ic ipa te d ca pi ta l expenditure s, our e stimates regarding our c apital require ments, a nd our ne ed for future capi ta l; our li quid it y and working ca pi ta l requirem ents; our expec ta tions regarding our revenues , e xpe ns es and other re sults of operat ions; the unpre dictabi li ty of the size of the ma rke ts for, and ma rke t acc eptance of, a ny of our produc ts, inc luding VE N 309; our abil it y to sel l any a pprove d products a nd the pri ce we are able re al iz e; our need to obta in a ddi tiona l funding to develop our produc ts, and our abi li ty to obta in future funding on a cce pta ble te rm s; our a bil it y to re ta in a nd hi re ne ce ssary e mployee s a nd to staff our operat ions a ppropriately; our a bi l it y to c ompete in our indus try a nd innovat ion by our compe ti tors; our a bil it y to s ta y abrea st of and comply with new or m odi fied la ws and re gulat ions tha t currentl y apply or be come appli ca ble to our busine ss; est im ates a nd est im ate m ethodologies used in preparing our fina ncial state me nts; the future t rading pric es of our c ommon stoc k and the impac t of s ecuri ti es analysts ’ re ports on the se pri ce s; and the ris ks set out in our fi li ngs with the SEC, inc luding our Annual Report on Form 10 - K. E stimates and forwa rd - looking sta te ments involve risks and uncertaint ies a nd are not guara ntee s of future pe rforma nc e. As a re sult of known a nd unknown ri sks a nd unce rta inties , including thos e de scribe d above, the est im ates and forwa rd - looking sta te ments dis cussed in this materia l might not occ ur and our future re sults and our performance might d iffe r material ly from those e xpre ssed in the se forward - looking sta te ments due to, including, but not limited to, the factors me nt ioned a bove . E stimates and forward - looking sta te ments spea k only a s of the date they were made , a nd, exc ept to the e xte nt re qui re d by la w, we underta ke no obligat ion to update or to re view any es timate and/or forward - looking sta te ment bec ause of ne w informa tion, future e vents or other fa ctors. Forward Looking Stateme nts

» A Phase III b iopha rmac euti ca l company focuse d exclusively on gast roente rology; spec ifi ca ll y, a na l disorde rs - a ne glec te d area of drug de velopme nt » Developme nt ri sk st ra ti fie d ac ross three late - sta ge products � NCE and 505(b)2 regis trat ion pa thways � Two pivota l Pha se III re ad - outs for two s eparate products e xpe cte d in 2Q 2012 � Poss ible val ida tion of two lead progra ms � Ra nge of co - promotion/partne rship opportunit ie s c ould fol low da ta » Products a ddress la rge , underserve d, a nd untapped ma rke ts � 3 of the top 10 GI dis orders � Signific ant ma rke t pote ntials in spec ia lt y pha rma and prima ry care » Wel l funded through ke y mi le stones � Ca sh and c ash e quivalents of $ 36. 9 Mil (Dec 31, 2011) � $20 m m IPO (wi th overal loc at ion ) in Dec 2010; $50 mm follow - on in July 2011 2 Compa ny Overvie w

Pipel ine 3 Progra m (Pathway) Indica tion Cl in ica l Pha se Potent ia l NDA Fil ing Commerc ia l Rights I II III VE N 309 Ife ranserin ( NCE ) He morrhoids 2014 World Wide , Unpartne red VEN 307 Di lt ia ze m (505(b)2 ) Anal Fissures 2013 North Ame rica , Unpartnere d VEN 308 (505(b)2) Fec al Inc ont ine nc e 2015 North Ame ric a , Unpartne re d La te Stage Pipel ine with Two Pivota l Pha se III Re ad - outs Expec te d in 2Q 2012 for Val idation of T wo Lea d Progra ms

VE N 309: Ifera ns erin NCE for Hemorrhoids

5 Hemorrhoids : A La rge , Underse rve d Market » 10,000 consumer surve ye d, 1,125 report suffe ring from hemorrhoids 1 : � Past two ye ars 11. 0% 25.8 mi ll ion 2 � Past yea r 9.3% 21. 7 mil li on 2 � Da y of survey 2.9% 6.7 mi ll ion 2 » Current trea tm ent opt ions: � Invasive proce dures : ba nding, sc le rosing agents, surgery for prolapse d hemorrhoids � Rx: No FDA a pprove d Rx drugs � 4+ mil li on pre scriptions of non - approved a nd non - DE SI int ra - anal steroids 3 � Minima l to no reimburs eme nt ; No other known drugs in dev. in US, E U* or Japan � OT C: 20 - 22 m il li on 3, 4 OTC units sold annua ll y in US (e. g. , Pre parat ion H ®) 85% reported us ing OTC or Rx tre atment at lea st onc e (86% OTC/14% Rx) ̂ 10% of a ll pat ie nts re ported having an inva sive proc edure (61% s urgery) wi th 75% report ing re curre nce of symptoms afte r surgery ̂ 3. IMS 2003 4. IMS 2009 * Ora l Daflon ha s a hemorrhoid indic at ion in France ̂ PBE survey of 10,202 c onsume rs 2011 1. Prince ton B rand Ec onome tri cs S urvey 2011. 2: ca lc ulated from the 2010 US Adult populat ion – 234,564, 000 (2010 US ce nsus )

6 Physiology of Hemorrhoids Increa sed intra - pe lv ic press ure Dilatat ion of the he morrhoidal p le xus , increa sed pres sure , swel ling L ocal s erotonin (5HT) re lea se 5HT2a re ce ptor ac ti vat ion Effere nt venous c onst ric tion & pla te le t aggre gat ion Inte rna l he morrhoid E xternal he morrhoid � VE N 309 Prima ry Symptoms: B le eding, It ching & Pa in

7 VEN 309 ( i fe ranserin ) Summa ry Topic al rec ta l o intme nt a ppl ie d int ra - anal ly B ID x 2 we eks (wi th proprietary single - use a ppl ic ator) Me chanism of Action » Sele ct ive 5HT2a anta gonist » Doe s not cross the blood brain barrie r exc ept at dos es muc h higher than to be use d the rapeuti ca ll y Prec lin ic al Safe ty » System ic exposure i s < 10% » Therape ut ic rat io is > 17x Cl in ica l Pha rm ac ology » Me ta bol iz ed by CYP2D6 in l ive r » No acc umula tion of the drug on twice dai ly dosing Cl in ical Da ta » Seven c lin ica l trial s in 359 s ubjec ts (220 exposure s) » No SAEs, limi ted AEs (ma inly GI), simi lar AE profil e vs. p la ce bo » Signific ant im proveme nts in symptoms related to hemorrhoids inc luding ble eding, pain and i tching

8 Effic acy Pha se IIb (Ge rman s tudy 1 ) � 121 pat ie nts ra ndomize d to VE N 309 ( ife ranserin ) B ID vs. p lac ebo ointm ent x 14 da ys � Wee kly v isi t s for 2 wee k tre atment ; fo l low - up a t 45 da ys � Sym ptoms rec orde d in da il y d ia ries (sca le of 1 - 10; 1 = no s ym ptoms) � Stat i sti ca ll y signifi ca nt improve ment in s ym ptoms: ble eding, i t ching, pa 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 1011121314 Day VEN 309 PL ACE BO Mean (B leed) Primary e ndpoint BLEE DING (n=111 pat ie nts) P < 0.05 1. Herold A, Diet ri ch J , Aitc hison R . Int ra - anal i fe ranserin 10 mg B ID for he morrhoid disea se: a pros pe ct ive, ra ndomiz ed, double - bl ind, plac ebo - cont rolled t rial . Cl in Ther . 2012;34(2):329 - 340. p<0.0001 p < 0. 0075

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 1011 12 13 14 Day E ffi ca cy Phas e IIb (Germa n study 1 ) Sec ondary e ndpoints: ra pid, sus ta ined 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 1011121314 Day * = P < 0.05 * ITCHING (n=60 pa tients) PAIN (n=40 pa tients) P < 0. 05 DAY 7 P < 0.0008; DAY 14 P < 0.02 * Me an (Itc h) Me an (Pa in) VE N 309 PLACEBO 1. He rold A, Die tric h J, Ait chison R. Intra - anal i fe ranserin 10 mg B ID for he morrhoid disea se: a pros pe ct ive, ra ndomiz ed, double - bl ind, plac ebo - cont rolled t rial . Cl in Ther . 2012;34(2):329 - 340.

10 Model ing of Phase IIb 1 Da ta for Pha se III Endpoints * Abse nce of symptom Da y 7 through Day 14 Majorit y of responde rs in the trea tm ent arm re spond by Da y 3 *Post hoc » Secondary Endpoints � It ching: � 59% vs. 32% � p<0.034 � Pain: � 50% vs. 18% � p<0.032 57% 20% 0% 10% 20% 30% 40% 50% 60% Ifera nse rin Plac ebo P = ≤ 0. 0001 PRIMARY E NDP OINT : No Blee ding from Day 7 to Da y 14 (2nd wee k of Tre atment) Re sponse 1. Herold A, Die tri ch J, Ai tc hison R . Intra - anal i fe ranserin 10 mg B ID for he morrhoid disea se: a pros pe ct ive, ra ndomiz ed, double - bl ind, plac ebo - cont rolled t rial . Cl in Ther . 2012;34(2):329 - 340.

Robus t, Disc ip l ined P ha se III Tria l Endpoints Mea ningful improvem ent (propose d by FDA) • Primary endpoint : ce ssat ion of b le eding da y 7 – 14 (>99% powe re d) • Secondary e ndpoints : c ess at ion of pain, i tc hing da y 7 – 14 (>95% powe re d) Design Three arms : • 7 da y / 14 day / p la ce bo • 200 pts per a rm • Ope n la bel extension to 1 yea r to trea t recurrence Si te s 70 US sites Inc lusion criteria Me aningful s ym ptoms ( blee ding, i tc hing, pain for 2 days ) to c le arly de monstrate thera peuti c effec t Progress • Disc uss ion with FDA on a ll ma jor e le ments of the protocol • Enrol li ng corre ct pat ie nts • Continuous data revie w (blind) • Minima l loss of ke y outcome data • Enrol lme nt c omple te end April 2012 • Re porting of results e xpe cted late June / e arly J uly 2012 11

12 De velopme nt Plan: Next Ste ps Chronic re pe ated use product (FDA de fin it ion, m ay not apply in Japa n/EU) » 1, 500 subje cts ne eded for c omplete safety profi le (US a nd possibly E U) � 7 cl in ic al t rial s in 359 subjec ts (220 e xposures) � 600 pat ie nts in Phas e III study de signed to provide progra m val ida tion � Second pivota l Pha se III trial p la nne d (and double blind Phase III rec urrenc e t ria l to de termine safety/e ffi ca cy a nd tre atm ent for re currence for the US) – wi ll ge ne rate a progra m total of > 1500 pts exposed to drug » Cl in ic al pharma cology program inc luding: DDI , PK in poor me tabol ize rs ( re sults e xpe cted Q2 ), QT a nd spec ial populat ions » Pre cl in ical : Chronic Tox a nd Ca rc inogenic it y studies (two spec ies for 2 yrs) » Ca rc inogenic it y i s cri ti ca l pa th for NDA, cl in i ca l t ria ls ca n be done s eria ll y

13 Pa tient /Pres cribe r Re sponse to VEN 309 1 » Strong wi ll i ngness to ask the ir doc tor for VEN 309 a t the ne xt v isit � For pa tients who are having symptom s now , (e st imate d at 6.7 m m) � 80% would* request a pre scription � In the whole sa mple : � 66% rec eiving a pre script ion would fi ll the Rx at a $35 out - of - pocke t co - pa y* � 78% with house hold inc ome a bove $50k/ye ar would fill the Rx a t a $35 copay* » He al th care provide rs showed high wi ll i ngness to pre scribe and m inima l co - pa y pri ce se nsit iv i ty � Probabi li ty of HCPs to grant a pa tient Rx re que st ranged from . 88 - .92* 1. Prince ton B rand Ec onome tric s Survey 2011. * PBE fa ctore d

VE N 307: Di lt ia ze m Crea m Novel Trea tm ent for Ana l Fissures

15 Ana l Fissures: Cause a nd Ma na geme nt Incre ase d sphincter tone L oc al i schem ia Te ar (fis sure ) in anal c anal Cause Seve re pain on defec at ion T re atment options Control constipat ion, topica l ste roids Reduce sphincter tone Compounded T opical drugs : • GT N* • di lt ia ze m Botox Surge ry Sphincters (musc le s) Anal fis sure 1.1 mm offi ce v is it s/ye ar Anal fi stu la * Re cti v (topic al GT N) rece ntl y approve d by FDA but not yet la unc hed

16 VE N 307 ( d il ti az em ) Summary 2% topical d i lt ia zem cre am applied peri - anal ly T ID Mec ha nism of Action » Ca lc ium c hannel b locke r � Re la xe s the inte rna l a nal sphincter, reducing pa in a nd incre asing ti ssue blood flow Prec linica l Safety » Pre cl in ical topica l safety wi th 2% dil ti az em twice dai ly for n ine ty da ys C linica l Pha rmac ology » Topica l ha s < 10% systemic exposure as oral dos e but signifi ca nt ly gre ater e ffe ct on sphincter tone – i.e ., b lood le vels do not predict ac ti v it y. L ow expos ure = be tter to lera bil it y than ora l di lt ia ze m C linic al Data » Ten c lin ic al trial s in 453 indiv iduals » Infrequent mild AEs reported » Simi la r or bet te r reduc tion in pa in, signifi ca nt ly be tter to le rabil ity tha n GTN

17 Pivotal Pha se III T rial » FDA (analgesia division) pre - IND mee ting conducted in Augus t 2007 � Ac hie ve d clari ty on prim ary endpoint: reduct ion in pain � Confi rmed safety databas e a nd tox require ment � NDA fil ing possible 2013 » Pha se III tria l conduc te d by SLA (E x - NA li ce ns or) � 3 arms, 155 pts pe r arm: 2% 4% di lt ia ze m TID , a nd plac ebo in 31 sites in E urope � Primary endpoint : re duc tion in pa in on defe cat ion using a va lidate d sc ale ( Like rt , NRS) � Ve ntrus re view of bl inded da ta and study ope ra tions 10/2011: Correc t pa tients e nrolled, data c ompliance and GCRP are good, data a re be ing reviewed continuously � Enrol lme nt c omple ted; data re adout expe cted in May 2012 » Planned Second Phase III t rial (s): � De veloping 4 possible extended re le ase formulat ions: may te st som e or a ll i n hum an ma nome try t ria l in 2012. Next phase could be 2 PH III t ria ls with extended relea se formulat ion if one i s ac ce pta ble, or 1 wi th orig ina l formula tion

18 Compet it ive Trea tm ents for Ana l Fissure 1 C ross, KLR . , et al ., (2008) The Manage ment of Anal Fis sure : ACPGBI Posi tion Statem ent . Colorec ta l Dise ase , 10 (Suppl . 3), 1 - 7. 2 Madoff , RD. , & Fleshma n , J W . (2003) AGA T echnical Review on the Diagnosis and Care of Pat ie nts With Anal Fis sure . Gast roenterology, 124, 235 – 245 Di lt ia zem is the rec ommended fi rst - li ne t re atment for ana l fi ssures among GIs a nd CRS The launch of Rec ti v ™ c ould a llow cost effec ti ve target ing of presc ribers and inc rea se AF awa reness Wi th our AE advanta ge , VEN 307 could ra pidly establi sh ma rke t dominance once la unc he d Rec ti v ™ 0. 4% GT N ointm ent BID (T opica l Ni troglyc erine ) Approved in the US for moderate and se ve re pa in of c hronic a na l fissure, launched Ma rc h 2012 Price d at $730 WAC per 8 we ek c ourse Extensive l iterature reporting improve d pain but d i ffi cult side effec t profile: h igh rate of he ada ches (64% of pat ie nts, often se vere), flushing, na usea a nd dizz iness Medical a ssociat ions ’ guide lines ha ve c onsiste ntl y d irec te d physicians to topica l di lt ia ze m over GT N a s 1st li ne therapy 1, 2 Calcium Cha nne l Bloc kers Compounded ni fe dipine i s used to a le sse r extent than di lt ia ze m Le ss li te ra ture avai la ble Botox Out of pocket c ost for pa tients Surge ry Forc ib le di la tat ion a nd sphincterotomy Most often curat ive, but fe ca l incontine nce is a proble m

Busine ss Ove rview, Milestone s

20 T arget Markets Provide Optimal St ra te gic Flexib ili ty » Spe cial ty sa le s force a nd DT C ca n be highly effec ti ve � Di lt i aze m is the re comme nde d first - li ne t re atment in foc used ma rke t of special is ts � 50% of current hemorrhoid scripts (4 m il li on) a re c onc ent ra te d in 21,000 presc ribers � No da ta to support the us e of intra anal steroids as effec ti ve t rea tme nt ; not a pproved � Di rec t To Consume r (DTC) advert ising could be highly impac tfu l for VE N 309 1 » Partne rships � We inte nd to se ek a ma rke ting partne r for VEN 309 for ex - US te rri tories � Co - promotion opportunit ie s exist for broade r PCP coverage of VEN 309 » Pricing and Reimburse ment � VE N 309: No othe r drugs in c la ss or indica tion: Medica re Pa rt D and ma na ged c are impl ic at ions � VE N 307: Pa rit y pri cing to Rec ti v ® ($ 730 two month supply) i s possible; Expec t major share of exist ing c ompounde d Rx, new Re ct iv ™ pat ie nts, p lus additional pat ie nts 1:Prince ton B ra nd Ec onomet ric s forecast model 2012

Rights a nd Exclusiv it y R ights » Ve ntrus has al l rights and t it le , W orld - wide, paying royal ties be tween 1% and 4% Market a nd Data E xc lusiv it y » Ne w c oncentra tion ra nge patent fil ed wi th USPT O & PTC (August 2010) » Composit ion of ma tter e xpi res August 2015 » 5 ye ars and 10 yea rs of data e xclusiv it y in the US unde r Hatch - Waxma n Act and E U, re spect ive ly » Topica l GI Product wi th low bioava ilabil it y 21 VEN 309 VE N 307 Rights » North American rights pa ying mid to upper single dig it royal ties Ma rke t and Data Exclusiv i ty » Me thod of use pa te nt e xpi res Feb 2018; a pprox. 16 months HW e xtension » Topica l GI product ; s ys te mic levels do not pre dict a ct iv it y » Extende d re le ase formula tions (B ID) unde r developm ent to e xtend e xclusiv it y

22 E xpe cted Mi le stones H1 2012 H2 2012 » PH 3 enrollment c omplet ion » Re sul ts from PH 3 t ria l (e xpe cted J une) » Cl in ic al pharma cology resul ts » Publ ic ation of pre cl in ical pharma cology » FDA mee ting » Re curre nce data re ad - outs from 1st p ivotal » Launch second pivota l and rec urre nc e tria l » Da ta publi cat ion/pres enta tion » Pate nt offic e ac tion VEN 309 VEN 307 » Da ta re ad - out from first p ivota l PH 3 t rial (e xpe cted in May) » Go/no go de cision a nd select ion of e xte nded re le ase formula tion » FDA mee ting » Launch of se cond pivota l » Re sul ts of new formula tion » Da ta publi cat ion/pres enta tion

23 Financials » Na sdaq (IPO 2011): VTUS » Ca sh balance � Ca sh and c ash e quivalents YE 2011 * $ 36.9 Mil » Stock da ta � Ful ly di luted share s outstanding 15.3 Mi l � Sha res outsta nding 12.4 Mi l * Includes $12. 5 mil payme nt for rights for VEN 309 to Amer & Co.

» De velopme nt ri sk st ra ti fie d ac ross three late - sta ge products � NCE and 505(b)2 regis trat ion pa thways � Two pivota l Pha se III re ad - outs for two s eparate products e xpe cte d in 2Q 2012 � Poss ible val ida tion of two lead progra ms � Ra nge of co - promotion/partne rship opportunit ie s c ould fol low da ta » Products a ddress la rge , underserve d, a nd untapped ma rke ts � 3 of the top 10 GI dis orders � Signific ant ma rke t pote ntials in spec ia lt y pha rma and prima ry care » Wel l funded through ke y mi le stones � Ca sh and c ash e quivalents of $ 37 mm (De c. 31, 2011) � $20 m m IPO (wi th overal loc at ion ) in Dec 2010; $50 mm follow - on in July 2011 24 Conc lusion

Russe ll H. El li son, MD, MSc Chie f Exec uti ve Offic er a nd Cha irma n of the Boa rd