BioLife Solutions Investor Presentation March 2017
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Transcript of BioLife Solutions Investor Presentation March 2017
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NASDAQ: BLFS
Corporate PresentationMarch 2017
Biopreservation Tools for Cells, Tissues and Organs
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SafeHarborStatementThis presentation contains forward-looking statements, including, but not limited to, statementsconcerning the company’s anticipated business and operations, the potential utility of and marketfor its products and services, potential revenue growth and market expansion, new products, andthird party projections regarding the future market for regenerative medicine and cold chainpackaging and instrumentation services. All statements other than statements of historical fact arestatements that could be deemed forward-looking statements. These statements are based onmanagement’s current expectations and beliefs and are subject to a number of risks, uncertaintiesand assumptions that could cause actual results to differ materially from those described in theforward-looking statements, including among other things, uncertainty regarding market adoptionof products; uncertainty regarding third party market projections; market volatility; competition;litigation; and those other factors described in our risk factors set forth in our filings with theSecurities and Exchange Commission from time to time, including our Annual Report on Form 10-Kand Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-lookingstatements contained herein or to reflect events or circumstances occurring after the date hereof,other than as may be required by applicable law.
2 © 2017 BIOLIFE SOLUTIONS, INC.
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Mission
Becometheleadingproviderofbiopreservationtoolsforcells,tissues,andorgans;
Bysupplyingbestinclasstoolsformaintainingthehealthandfunctionofbiologicsourcematerialandfinishedproductsduringmanufacturing,storageanddistribution.
3
WHAT
WHY
HOW
Tofacilitatebasicandappliedresearchandcommercializationofnewbiologic-basedtherapies;
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ExperiencedExecutiveTeamMikeRice– ChiefExecutiveOfficerBSBusAdmin;10yearsasBLFSCEO;chiefvisionaryofBLFSmarketopportunities,branding,marketingstrategies;18yearsmedicaldevicesales,salesmanagement,marketing;patientmonitoring,defibrillators,implantableCRM,hearingdevices,LAN/WAN;5issuedand13pendingpatents
AbyJ.Mathew,PhD– CTO,SeniorVicePresidentBSMicrobiology,PhD,Cell&MolecularBiology;co-developerofplatformHypoThermosol®media;indemandindustrythoughtleaderinbiopreservationofcellsandtissuesforclinicalapplications;catalystresponsiblefordrivingregenmedmarkettoadoptBLFSclinicalgradebiopreservationmedia;6issuedand6pendingpatents;numerousjournalarticles
RoderickdeGreef– ChiefFinancialOfficerBAEconomics,MBA;25yearsCFOexperiencefor5publiccompanies;Serves/servedon4USpubliccompanyboardsincludingEndologix(NASDAQ:ELGX);Raised>$200mmfromUS,EUandAPprivateandinstitutionalinvestors;Structured,negotiatedandclosed$400mmofpubliccompanymergersandacquisitiontransactionsintheUSandEurope
KarenFoster– VicePresident,OperationsBSBiologicalSciences,MSZoology,MBA;25yearcareerinqualityandmanufacturingoperationsincluding13yearsVPManufacturingOperationsandSiteLeaderatViaCord,2positionsleading80memberteams;certifiedSixSigmaGreenBelt.
JimMathers– VicePresident,GlobalSalesBA,Biology,MBA;35yearssalesandsalesandmarketingmanagement;repeatedachievementindrivingearlyadoptionofnewmedicaldevicetechnologiesforStryker,MAKOSurgical,BrainLab,AccuRay,CardiacScience,JNJ
ToddBerard– VicePresident,MarketingBS,Biochemistry,MBA;16yearsmarketingincludingleadershipofmarcom,corporatebranding,productmarketing,andpositioningforVerathon,PhysioControl(MDT),techstartups
© 2017 BIOLIFE SOLUTIONS, INC.
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OurBiopreservationTools
Mediadesignedtopreservebiologicsduringexvivostorageandshipment
Goal:maximizeeffectivenessofbiologicbasedmedicine
Smart,cloud-connectedshippingcontainersengineeredtomaintainstabilityoftimeandtemperaturesensitivebiologicmaterialsfromveintovein
TM TM
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WorldwideCustomerBase
392
• 33 Countries• 530 Direct Customers• Excludes Distributor
End Customers
21
61
15
8
246
3
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ExecutingtoDriveGrowth
>500CUSTOMERS
>250REGENMED
APPLICATIONS
PRODUCTADOPTION
2016RECORD
REVENUEOF$8.2MM
28%YoYGROWTH
250PUBLISHEDPAPERS,
POSTERSandABSTRACTS
EVIDENCE
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ApplicationsforBiologicMaterials
SolidOrgans
Tumor
TissueBiopsies
Apheresis
BoneMarrow AllogeneicTransplant
Biobanking
DrugDiscovery
RegenerativeMedicine
AutologousCellTherapy
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BiopreservationMarket
Source: Biopreservation Market Size By Product (Equipment, Media, Laboratory Information Management System), By Application (Regenerative Medicine, Biobanking, DrugDiscovery), Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, Japan, China, Brazil, Mexico, South Africa), Growth Potential, Price Trends, Competitive MarketShare & Forecast, 2016 – 2024. Global Market Research; Published September 2016
Addressablemediasegment
14%CAGR;drivenbyRegenerativeMedicinesegment
demand
Hardware Media LIMS
2024– $9.7BTotalSpend
Hardware Media LIMS
$448MAddressablein
Media
$1.3BAddressablein
Media
2016- $3.5BTotalSpend
Drivingchangefromusinghomebrew
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BiopreservationChallenges
Survival– HowLong Viability– HowMuch Function– HowWell
ExVivoTime
Viab
ility
ExVivoTime
Survival
ExVivoTime
Functio
n
Cold storage is used to preserve biologic integrity and function bylowering metabolism.
Whenremovedfromthebody– cells,tissues,andorgansdegradeanddie– araceagainsttime!
Traditionalmethodsandtoolsarenotoptimizedandofferlimitedprotectionfrompreservation-inducedstress,injury,anddeath.
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ImprovedPreservationYield:LowerCustomerCOGS
YieldYield
Cost Cost
LESSRequiredto
AchieveDesiredTherapeutic
Effect
SourceMaterial ManufacturedCellProducts
LESSRequired
MOREDoses=
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Serum-free,protein-free,animaloriginfree;highestqualityingredients;USFDAMasterFile
12
CryoStor®FreezeMedia
Improvedcellviabilityandfunctionalrecoverycomparedtocommercialandhome-brew
alternativesinnumerouscelltypes
Formulatedtomitigatemolecularcellstressduringfreeze/thawprocessincordbloodstem
cells,Tcells,others
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HypoThermosol®StorageMedia
Optimizedforhypothermic(2-8°C)storageandshippingofcellsandtissues
Enablesmultipledaysofcellandtissuestoragefortransportofsourcematerialandmanufacturedcell
productsthroughouttheworld
Serum-free,protein-free,animaloriginfree;USPingredients;USFDAMasterFile
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CellsPreservedintraditional“homebrew”
Humanmesenchymalstemcellsisolatedfrombonemarrow;conditionofcellsafter5daysofcoldstorage,thenreturnedtocultureconditionsandassayed24hourslater
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ProductPerformanceCellsPreservedinHypoThermosol®
Deadcells
Healthycells
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3StrategicRevenueMarkets
REGENERATIVEMEDICINE
Celltherapycompanies
Hospital-basedstemcelltransplantcenters
University-basedclinicalresearchlabs
CelltherapyCDMO,CRO
DRUGDISCOVERY
Pharmaceuticalcompanies
Cellsuppliers
Toxicitytestinglabs
Personalizedmedicinelabs
BIOBANKING
Umbilicalcordbloodbanks
Adultstemcellbanks
Tissuebanks
Biorepositories
Hairtransplantphysicians
15%OF2016
45%OF2016
40%OF2016
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RegenerativeMedicineOpportunity
16 © 2017 BIOLIFE SOLUTIONS, INC.
$16B Invested in 2015 - 2016
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SourceMaterial
PreservationMedia
CellFactory
ManufacturedProducts
TemperatureControlledContainer
PreservationMedia
4EngagementOpportunities:Mediaand ColdChainforSource
Materialand FinalDosePatient
TemperatureControlledContainer
TemperatureControlledContainer
© 2017 BIOLIFE SOLUTIONS, INC.
CellTherapyManufacturingWorkflowVeintoVeinCustomerEngagement
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CustomersTargetingAllMajorDiseaseStates
18 © 2017 BIOLIFE SOLUTIONS, INC.
Immune
Stroke
Cardiac
Diabetes
HIV
OA
PADCLI
GVHD
Cancer
KidneyDisease
ALZ
Spinal
>250REGENMED
APPLICATIONS
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MarqueeCustomersDISTRIBUTORS CMO & CDMODIRECT – 100 REGEN MED
COMPANIES
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EngagementStrength“OverthelastseveralyearswehaveworkedtoqualifyandadoptCryoStorinourclinicalmanufacturingprocess.Wearenowsecuringlongtermsupplycontinuityforthisreagentasourcelltherapyproductcandidatecontinuestoprogressthroughmultipleclinicaltrials."
Marc Better, PhDVice President, Product Sciences
CUSTOMER: KITEPHARMA
CELLTHERAPIESINDEVELOPMENTS:
CARTCELLPLATFORMFORVARIOUSCANCERS
BIOLIFEPRODUCTUSED: CRYOSTOR®
APPLICATIONOFBIOLIFEPRODUCT:
FREEZINGEVERYDOSEAFTERMANUFACTURINGTOENABLESTORAGEANDDISTRIBUTIONTOCLINIC
RELATIONSHIPENGAGEMENT:
10-YEARSUPPLYAGREEMENT
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RegenMedMarketPotential
AnnualBioLifeRevenuePerCustomerApproval:$500,000- $2,000,000
X =X
X
X
X
X =
=
AnnualDosesProduced BioLifeProductUsedPerDose(mL) PricepermL AnnualRevenue
RareCancer(2.5K)
CommonCancer(10K)
Osteoarthritis(200K)
X
X =3.5ml $3.00 $2.1M
60ml $3.00 $1.8M
60ml $3.00 $450K
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Intelligent,Informed,PreciseBiologicMaterialsManagement
evo®ColdChain2.0™
Cloud-BasedColdChainManagement
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TraditionalPharmaColdChain
80-130millionannualtemperaturesensitiveshipmentsrequiringcoldchainlogistics1
$15- $35billionspentannuallyreplacingproductslostduetotemperatureexcursions1
6%ofrevenuespentonlogistics2 yettheaverageperdoseexpenseforcoldchainisdeminimis
1ChainLinkResearch 2PharmaceuticalCommerce2016ColdChainSourcebook
$12billionspentannuallyoncoldchainlogistics
$9B
$3B
Specializedtertiarypackagingandinstrumentation
Transportation
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CellTherapyColdChainDynamics
Reimbursementat$100K- >$500K
Fullyburdenedmanufacturingcostperdosecouldrangefrom
$30K- >$50KIndividualdosedelivery
failure
Significantperdose coldchain
expenseisrationalyetunappreciated
Celldeathfromtemperatureexcursionsintransit
Criticalrisks
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CompetitiveShippers:Inadequate
Foam Coolers
• Oldtechnology• Marginalperformance• Single-use
DataLoggers
• Recordscontainer,notpayloadtemperature
• Datareviewedafterclinicalproductisused
VacuumPanelShippers
• Overlycomplex• Heavy,expensivetoship• Pronetopackouterrors
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Risks– BrokenColdChain
Economic
CostofscrappingbiologicsourcematerialormanufacturedcellproductsClinicaltrialimpactfrompoorbiologisticsmanagement;lostdoses,poorshippingcontainerperformance,temperatureexcursions,trialfailure,fundingexposure,reimbursementexposure
$ClinicalRx
Unknowinglyadministeringathermallysensitivebiologicdosethatwasexposedtoundetectedtemperatureexcursions,packouterrorsorhasexceededitstabilityperiod
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PatentsPending
27
OurSolutionevo®ColdChain2.0™
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2-8°CUsewith
pre-conditionedcoldpacks
28
Cloud-ConnectedSmartShippers
CRT15°C- 20°C
Usewithpre-conditionedcold
packs
CRYO-80°C
Usewithdryice
PatentsPending© 2017 BIOLIFE SOLUTIONS, INC.
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evo™SmartShipper
Integrated cell phone with real time location and payload monitoring via SaaS
Durable and reusable – designed for harsh small parcel shipping environment
Intuitive, universalpack-out; ALL SEASON™ Cold Packs; eliminates
packout errors
True payload temp monitored via integrated thermocouple (temperature, humidity, tilt)
Cold pack
Cold pack
Payload Carrier
Integratedthermocouple
Cell phone
Super insulation
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evo®SystemPerformance"We have been extremely pleased with theperformance of the evo® Cold Chain 2.0™ systemfor use in our phase 3 study. The unique uni-directional packout prevents errors in packagingand makes it very simple for our clinical sites topackage the starting apheresis product forshipment to our manufacturing facilities.Validation of tight temperature stability in everyshipment is critical, and we have not experiencedany temperature or packaging deviations sinceswitching to evo. It is clear that an enormousamount of thought and testing went in to thedesign of the evo system."
Marta SchillingVice President, Cell Therapy Manufacturing
CUSTOMER: IMMUNOCELLULAR
CELLTHERAPIESINDEVELOPMENTS:
DENDRITICCELLPLATFORMFORVARIOUSCANCERS
PRODUCTUSED: evo®SMARTSHIPPER
PRODUCTAPPLICATION:
COLDCHAIN2.0™SHIPMENTOFAPHERESIS
FOREVERYMANUFACTUREDDOSE
RELATIONSHIPENGAGEMENT:
120SITE,400+PATIENTSPHASE3TRIAL
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biologistexJVRestructuring
• Allevo®SmartShipperandbiologistex™ColdChainSaaSIPandassetsnowconsolidatedinoneentitytoenableadditionalexternalinvestmentsintheJV;NotdependentonBioLifefunding
• BioLifeistheexclusivedistributortotheworldwideregenmedmarket• BioLifeholdsasignificantequitypositionandwillcontinuetoexclusivelymarket,sellandsupportcustomersintheregenmedspace
• 20%revenueshareforfirst3years
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FinancialInformation
32 © 2017 BIOLIFE SOLUTIONS, INC.
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BiopreservationMediaRevenueGrowth
$0
$1,000,000
$2,000,000
$3,000,000
$4,000,000
$5,000,000
$6,000,000
$7,000,000
$8,000,000
$9,000,000
2012 2013 2014 2015 2016
29%CAGR2012–2016
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2017Catalysts• Celltherapycustomers,includingKitePharma,areexpectedtoreceiveregulatoryapprovalstocommencemarketingandcommercialmanufacturing,which,asaresult,shoulddriveincreaseddemandforourproprietarybiopreservationmediaproducts.
• ContinuedadoptionofCryoStor®andHypoThermosol®inpre-INDvalidationsandphase1,2and3clinicaltrialsofnewcellandtissuebasedproductsandtherapies.
• AdoptionoftheevoSmartShipperandColdChainManagementSaaSbyleadingCARTcelltherapycustomers.
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2017Guidance• Biopreservationmediarevenuegrowthof20%- 25%over2016;revenueinexcessof $10million
• Grossmargininarangeof55%to60%• Operatingexpensesrangingfrom $8- $9million,reflectingaquarterlydecreaseof $400,000- $500,000 resultingfromtherestructuringofthebiologistexjointventure
• Restructureddebt• PositivequarterlyEBITDASbytheendof2017
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OperatingLeverage• TwoindependentcGMPformulationandfillsuites
• 100,000literannualcapacityincurrentfacilities
• NosignificantCAPEXrequiredtorealize10Xcurrentproductionlevel
• Potential10+ percentagepointgrossmarginincreaseasdemandramps
• MinimalSG&Aexpenseincreasesneededtorealizefullproductionandmarginpotential
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CapitalizationTable
37
§ 6.9Mpricedat$4.75§ 4.0Mheldbythesametwo
longtermshareholders
§ Managementandemployeeincentives
§ 1.6Mvested§ $1.83wt.avgexerciseprice
§ Limitedinstitutionalholders§ 48%heldbytwolongterm
shareholders
Shares– 13.3M
Directors&Officers Affiliates Other
Warrants– 7.6M
Directors&Officers Affiliates Other
Options– 2.3M
Directors&Officers Affiliates Other
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SharePrice
© 2017 BIOLIFE SOLUTIONS, INC.38
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
$0.00
$0.50
$1.00
$1.50
$2.00
$2.50
1/1/16 2/1/16 3/1/16 4/1/16 5/1/16 6/1/16 7/1/16 8/1/16 9/1/16 10/1/16 11/1/16 12/1/16 1/1/17 2/1/17
Volume Price
10YearSupplyAgreementPressReleaseIssued
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NASDAQ:BLFS
Foradditionalquestionsorcomments,pleasecontact:
MikeRice|[email protected] |(425)686-6003
RoderickdeGreef|[email protected] |(425)686-6002
www.biolifesolutions.com
BioLifeSolutions,Inc.3303MonteVillaParkway,Suite310Bothell,WA98021
39 © 2017 BIOLIFE SOLUTIONS, INC.