cardica, inc. 2007 annual report · cardica, inc. 2007 annual report ... financial strength •...
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C-Port xA Head Configuration
Cardica designs and manufactures proprietary products that automate the connections, or anastomoses, of blood vessels during coronary artery bypass graft (CABG) and other grafting surgeries.
CommerCial Progress
•IncreasedthecumulativenumberofsurgeonstrainedintheUnitedStatesonC-Port® Distal Anastomosis Systems to 163
•IncreasedcumulativeworldwideshipmentsofC-Portsystemstoover1,900units
•Received510(k)clearancefromtheU.S.FoodandDrugAdministration(FDA)tomarketthe C-Port® xA Distal Anastomosis System (November 2006)
•Received510(k)clearancefromtheFDAtomarkettheC-Port® Flex A Anastomosis System, avariationoftheC-PortxAsystemproductlinethatfurtherfacilitatesautomatedanastomosisduring minimally invasive CABG procedures (March 2007)
•Increasedsell-throughofthePAS-Port®ProximalAnastomosisSysteminJapanfromanaverageof 120 units per month in fiscal 2006 to an average of over 150 units per month in fiscal 2007
•IncreasedcumulativeworldwideshipmentsofPAS-Portsystemstoover5,900units
•ExtendedthePAS-PortsystemdistributionagreementwithCenturyMedicalthroughJuly2014(April 2007)
•Presenteddatahighlightinglong-termpatencyfortheC-PortandPAS-Portsystemsatkey national and international medical meetings
CliniCal DeveloPment anD Collaborations
•CompletedpatientenrollmentinapivotalclinicaltrialtoevaluatethesafetyandefficacyofthePAS-Portsystemduringbypasssurgery(March2007)
•MadesubstantialprogressinthedevelopmentandtoolingoftheCookVascularClosureDevice,resultinginthereceiptof$1.75millioninadditionalmilestonepaymentsfromCookMedical
•EnteredintoanewagreementwithCookMedicaltodevelopandcommercializeaspecializeddevicedesignedtoclosethepatentforamenovale(PFO),arelativelycommonheartdefectpresentinapproximately15to20percentofthegeneralpopulation(June2007)
FinanCial strength
•Raised$10.9millioninnetproceedsfromthesaleofCardica’scommonstockandwarrants (June2007)
•Reducedlong-termdebtfromapproximately$16millionto$2million
Fiscal 2007 Accomplishments
Fiscal2007wasayearofremarkableachievementforCardica.Our
innovative products are gaining acceptance and clinical adoption for
the automation of the connection, or anastomosis, of blood vessels
during bypass surgery, which is often considered the most critical aspect
oftheprocedure.Eachoftheyear’saccomplishmentscontributesto
ourmarketpositionandbuildsmomentumfortheyearsahead.
WebelievethattheclinicaladoptionofourC-Portsystemsandour
successingainingU.S.andEuropeanregulatoryclearancesforour
C-Portsystemsreflectthequality,reliabilityandconsistencyofour
proprietaryanastomosisproducts.InJapan,sell-throughratesfor
ourPAS-Portsystemincreased25percentforthesecondconsecutive
year,andintheU.S.andEurope,wecompletedenrollmentinapivotal
clinicaltrialforthisuniquedevice.Throughtwoindependentcollaborations
withCookMedical,weareusingourproprietarymicrocliptechnology
toaddressthegrowingmarketneedfornext-generationclosuredevices,
specificallytargetingthepatentforamenovale(PFO)andvascular
accesssites.Tostrengthenourbalancesheet,wereducedourdebt
substantially from approximately $16 million to $2 million, and we
completedanequityprivateplacementresultingin$10.9millionin
net proceeds to Cardica.
Wearebeginningtorealizeourvisionofenablingless-invasive,
sometimescalledsternum-sparing,bypassprocedures.Withsafety
concernsplaguingstentsandtheadoptionofless-invasiveCABG
surgery methods growing, we believe that many cardiologists will
increasingly recommend CABG surgery to patients with cardiovascular
diseasebecauseofitsprovenlong-termefficacyandlowermortality,
andadecreasedneedforre-interventioncomparedtostents.
C-Port sYstems: groWing PhYsiCian aDoPtion
In our first full fiscal yearofcommercializationofourC-Port
systemsintheU.S.,wehaveseenincreasedcommercialadoption
from cardiothoracic surgeons at bypass centers across the country,
manyofwhomuseourproductsonaroutinebasis.Overthecourse
oftheyear,weexpandedourC-Portproductlinewiththeintroductionof
ourC-Port®xADistalAnastomosisSystem,ournext-generationC-Port
systemwithenhancedfeatures,andtheC-Port® Flex A Anastomosis
System,avariationoftheC-PortxAsystemwithaflexibleshaftthat
allows surgeons to perform anastomoses in areas of the heart that are
particularlydifficulttoreachandhand-suture.Wehaveshippedover
1,900C-Portsystemsworldwideandhavetrainedatotalof163
surgeonsintheUnitedStatessinceweintroducedtheC-Portsystem
in the second half of fiscal 2006. During fiscal 2007, we added four
salespeople, bringing our sales force to ten.
Moving forward, we expect to continue to expand our user base,
facilitate routine usage by trained physicians and maintain our
strongcommitmenttothehighest-qualitycustomerserviceand
follow-up.Weplantointroduceacartridge-basedC-Portsystem
formultipledeploymentsandplantolaunchtheC-Port®xVDistal
AnastomosisSystem,anextensionoftheC-Portproductline
designed to accommodate larger grafts. With the addition of the
C-PortxVsystem,webelievethatwewillbeofferingafullspectrum
of devices that will allow surgeons to complete over 90 percent of all
distal anastomoses and all of the bypass conduits typically employed
in these procedures.
PAS-Port Deployment
To Our Stockholders
Pas-Port sYstem: ContinUeD marKet groWth
InJapan,whereCenturyMedicaldistributesourPAS-Portsystem,
salescontinuetogrow.Infiscal2007,weincreasedthesell-through
inthismarkettoanaverageofover150unitspermonth,witha
cumulativetotalofover5,900PAS-Portunitsshippedworldwide.
Based on our successful partnership with Century, we extended
our distribution agreement by five years, with it now scheduled to
continue until 2014. We believe that this extension is a testament to
our productive partnership and the value of our proprietary product
inthismarket.
IntheU.S.andEurope,wecompletedenrollmentofourpivotal
clinicaltrialtoevaluatethesafetyandefficacyofthePAS-Port
system during CABG surgery in approximately 220 patients. All
patientswererandomizedtoreceivebothaPAS-Portautomated
anastomosisandahand-sewnanastomosisasacontrol.Weintendto
submita510(k)applicationtotheFDAinthefirsthalfofcalendar
year 2008 assuming successful trial results.
neW marKet oPPortUnities
We are expanding the reach of our proprietary technology through
twoindependentpartnershipswithCookMedical.Overthecourse
of the year, we made substantial progress in the development of the
CookVascularClosureDevice,formerlycalledtheX-Port®Vascular
Access Closure Device, and received an additional $1.75 million
inmilestonepayments.WeexpectCooktolaunchthisproductin
Europeinthefirsthalfoffiscal2008.
InadditiontotheCookVascularClosureDevice,wesigneda
newagreementwithCookMedicaltodevelopandcommercialize
aspecializeddevicedesignedtoclosethepatentforamenovale
(PFO),acongenitalheartdefectpresentinabout15to20percent
ofthegeneralpopulation.Thispartnershipallowsustoleverageour
proprietary technology to potentially offer a new treatment alternative
forpatientswhohaveexperiencedtransientischemicattack,stroke,
paradoxical embolism or debilitating migraine headaches.
It has been a tremendous year at Cardica, and we believe that our
momentumisbuilding.Iwanttothankeachofthemembersofthe
Cardica team for contributing to a year of excellence, express my
gratitude to our customers who are using our devices on a routine
basis to perform bypass procedures and extend our appreciation to
ourinvestorsfortheircontinuedsupport.Lookingahead,weintendto
continue to expand our product offerings to further enable minimally
invasiveCABGsurgery.Welookforwardtoreportingourprogress.
Sincerely,
C-Port Deployment
Bernard A. Hausen,M.D.,Ph.D.
PresidentandChiefExecutiveOfficer
KevinT.Larkin
Chairman of the Board
Cardica designs and manufactures proprietary automated products
thataredesignedtoreplacehand-sewnanastomoses,whichare
time consuming and difficult to perform.
Our Products
C-Port® sYstems Pas-Port® sYstem
Pas-Port® Proximal anastomosis sYstem
OurPAS-Portsystemisafullyautomateddeviceusedtoperforman
anastomosisbetweenasaphenousveinandtheaortaduringeitheron-or
off-pumpCABGsurgery.ThePAS-Portsystemisapprovedforsaleand
marketedinEuropeandJapan.
Pas-Port sYstem
•allowsthesurgeontocompletetheanastomosisrapidly,typicallyin approximately two minutes;
•isusedwithoutclampingtheaorta,potentiallyavoidingassociatedriskssuchasstrokeandneurologicalcomplications;
•attachestheveingraftsecurelytotheaortainsecondsoncethevein graft is loaded; and
•producesconsistent,reproducibleanastomoses,largelyindependentofsurgicaltechniqueandskillset.
C-Port® Distal anastomosis sYstem
OurC-Portsystemsaredesignedtoperformadistalanastomosisby
attaching the end of a bypass vein graft to a coronary artery using
miniaturestainlesssteelstaples.Incontrasttoanon-compliant
hand-sewnanastomosisusingacontinuoussuture,thecompliant
natureoftheC-Portanastomosispotentiallyallowstheconnection
toadapttochangesinbloodfloworpressure.
C-Port sYstems
•canbeusedon-oroff-bypasspump(forstoppedheartorbeatingheart CABG surgeries);
•createcompliantanastomosesthatexpandandcontractwithbloodflow;
•reducetimerequiredforananastomosisfrom10-15minutestoaslittle as two minutes;
•produceconsistent,reproducibleanastomoses,largelyindependentofsurgicaltechniqueandskillset;
•donotrequireinterruptionofbloodflowwhiletheanastomosisisbeing completed; and
•workonverysmallcoronaryarteries.
InadditiontothefeaturesoftheC-Portsystem,theC-Port
Flex A system
•hasaflexible,ratherthanrigid,shaft;
•allowssurgeonstopositionthedevicetocreateasecure connection in more difficult to reach areas of the heart; and
•helpsfacilitateminimallyinvasiveCABGsurgerywitha surgical robot.
boarD oF DireCtors
KevinT.Larkin Chairman of the Board Cardica, Inc. and PresidentandChiefExecutiveOfficer TherOx,Inc.
J.MichaelEgan ChiefExecutiveOfficer SteadmanHawkinsResearchFoundation
BernardA.Hausen,M.D.,Ph.D. President,ChiefExecutiveOfficer andCo-founder Cardica, Inc.
RichardP.Powers VicePresidentand ChiefFinancialOfficer Anesiva, Inc.
JeffreyL.Purvin Chairman,Presidentand ChiefExecutiveOfficer SeattleMedicalTechnologies,Inc.
Robert C. Robbins, M.D. Chairman, Department of Cardiothoracic Surgery,StanfordUniversitySchoolofMedicine and Director, Stanford Cardiovascular Institute
JohnSimon,Ph.D. Managing Director Allen & Company LLC
StephenA.Yencho,Ph.D. President Water of Life, LLC
WilliamH.Younger,Jr. Managing Director SutterHillVentures
management team
BernardA.Hausen,M.D.,Ph.D. President,ChiefExecutiveOfficer andCo-founder
DouglasT.Ellison VicePresident WorldwideSalesandMarketing
BryanD.Knodel,Ph.D. VicePresident Research and Development
Robert Y. Newell ChiefFinancialOfficerand VicePresident FinanceandOperations
Ric Ruedy VicePresident Regulatory, Clinical and Quality Affairs annUal meeting
Theannualmeetingofstockholderswillbeheldon November14,2007at11:30a.m.Pacific time at Cardica, Inc., 900 Saginaw Drive, Redwood City, California. investor inFormation
Recent press releases and other Cardica infor-mation are available without charge on Cardica’swebsiteatwww.cardica.comoruponwrittenrequestto:
Cardica, Inc. 900 Saginaw Drive Redwood City, CA 94063 Tel:(650)364-9975 Fax:(650)364-3134 Email:[email protected] stoCK listing
Cardica’scommonstocktradesontheNasdaqGlobalMarketunderthe symbol CRDC. transFer agent
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inDePenDent registereD
PUbliC aCCoUnting Firm
Ernst&YoungLLP Palo Alto, California CorPorate CoUnsel
CooleyGodwardKronishLLP PaloAlto, California
ForWarD looKing statements
ThisAnnualReportcontains“forward-looking”
statements, including statements relating to
commercialization,developmentandregulatory
expectationsforCardica’sC-PortDistalAnastomosis
systems,includingtheC-PortxAandFlexA
systems,PAS-PortProximalAnastomosissystem,
CookVascularClosureDeviceandotherproducts
and product candidates. Any statements contained
in this Annual Report that are not historical facts
maybedeemedtobeforward-lookingstatements.
Thewords“believe”,“plan”,“expect”,“estimate”,
“intend”and“will”orsimilarexpressionsare
intendedtoidentifyforward-lookingstatements.
Thereareanumberofimportantfactorsthatcould
causeCardica’sresultstodiffermateriallyfrom
thoseindicatedbytheseforward-lookingstatements,
includingrisksassociatedwithmarketacceptance
ofCardica’sC-PortDistalAnastomosissystems,
manufacturingoftheC-PortDistalAnastomosis
systemsandPAS-PortProximalAnastomosissystem,
Cardica’ssales,marketinganddistributionstrategy
and capabilities, the timing and success of clinical
studiesrelatedtotheCookVascularAccessDevice
and the timing of completion and success of the
multi-nationalclinicaltrialusingCardica’sPAS-Port
system,aswellasotherrisksdetailedfromtimeto
timeinCardica’sSECreports,includingitsAnnual
ReportonForm10-KforthefiscalyearendedJune
30,2007.Cardicadoesnotundertakeanyobligation
toupdateforward-lookingstatements.Youare
encouragedtoreadCardica’sreportsfiledwiththe
U.S.SecuritiesandExchangeCommission,available
at www.sec.gov.
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