biolife solutions investor presentation march 2017

NASDAQ: BLFS

Corporate PresentationMarch 2017

Biopreservation Tools for Cells, Tissues and Organs

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.

Mission

Becometheleadingproviderofbiopreservationtoolsforcells,tissues,andorgans;

Bysupplyingbestinclasstoolsformaintainingthehealthandfunctionofbiologicsourcematerialandfinishedproductsduringmanufacturing,storageanddistribution.

3

WHAT

WHY

HOW

Tofacilitatebasicandappliedresearchandcommercializationofnewbiologic-basedtherapies;

© 2017 BIOLIFE SOLUTIONS, INC.

4

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


5

OurBiopreservationTools

Mediadesignedtopreservebiologicsduringexvivostorageandshipment

Goal:maximizeeffectivenessofbiologicbasedmedicine

Smart,cloud-connectedshippingcontainersengineeredtomaintainstabilityoftimeandtemperaturesensitivebiologicmaterialsfromveintovein

TM TM


WorldwideCustomerBase

392

• 33 Countries• 530 Direct Customers• Excludes Distributor

End Customers

21

61

15

8

246

3


7

ExecutingtoDriveGrowth

>500CUSTOMERS

>250REGENMED

APPLICATIONS

PRODUCTADOPTION

2016RECORD

REVENUEOF$8.2MM

28%YoYGROWTH

250PUBLISHEDPAPERS,

POSTERSandABSTRACTS

EVIDENCE


8

ApplicationsforBiologicMaterials

SolidOrgans

Tumor

TissueBiopsies

Apheresis

BoneMarrow AllogeneicTransplant

Biobanking

DrugDiscovery

RegenerativeMedicine

AutologousCellTherapy


9

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


10

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.


11

ImprovedPreservationYield:LowerCustomerCOGS

YieldYield

Cost Cost

LESSRequiredto

AchieveDesiredTherapeutic

Effect

SourceMaterial ManufacturedCellProducts

LESSRequired

MOREDoses=


Serum-free,protein-free,animaloriginfree;highestqualityingredients;USFDAMasterFile

12

CryoStor®FreezeMedia

Improvedcellviabilityandfunctionalrecoverycomparedtocommercialandhome-brew

alternativesinnumerouscelltypes

Formulatedtomitigatemolecularcellstressduringfreeze/thawprocessincordbloodstem

cells,Tcells,others


13

HypoThermosol®StorageMedia

Optimizedforhypothermic(2-8°C)storageandshippingofcellsandtissues

Enablesmultipledaysofcellandtissuestoragefortransportofsourcematerialandmanufacturedcell

productsthroughouttheworld

Serum-free,protein-free,animaloriginfree;USPingredients;USFDAMasterFile


CellsPreservedintraditional“homebrew”

Humanmesenchymalstemcellsisolatedfrombonemarrow;conditionofcellsafter5daysofcoldstorage,thenreturnedtocultureconditionsandassayed24hourslater

14

ProductPerformanceCellsPreservedinHypoThermosol®

Deadcells

Healthycells


15

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

RegenerativeMedicineOpportunity


$16B Invested in 2015 - 2016

17

SourceMaterial

PreservationMedia

CellFactory

ManufacturedProducts

TemperatureControlledContainer

PreservationMedia

4EngagementOpportunities:Mediaand ColdChainforSource

Materialand FinalDosePatient




CellTherapyManufacturingWorkflowVeintoVeinCustomerEngagement

CustomersTargetingAllMajorDiseaseStates


Immune

Stroke

Cardiac

Diabetes

HIV

OA

PADCLI

GVHD

Cancer

KidneyDisease

ALZ

Spinal

>250REGENMED

APPLICATIONS

19

MarqueeCustomersDISTRIBUTORS CMO & CDMODIRECT – 100 REGEN MED

COMPANIES


EngagementStrength“OverthelastseveralyearswehaveworkedtoqualifyandadoptCryoStorinourclinicalmanufacturingprocess.Wearenowsecuringlongtermsupplycontinuityforthisreagentasourcelltherapyproductcandidatecontinuestoprogressthroughmultipleclinicaltrials."

Marc Better, PhDVice President, Product Sciences

CUSTOMER: KITEPHARMA

CELLTHERAPIESINDEVELOPMENTS:

CARTCELLPLATFORMFORVARIOUSCANCERS

BIOLIFEPRODUCTUSED: CRYOSTOR®

APPLICATIONOFBIOLIFEPRODUCT:

FREEZINGEVERYDOSEAFTERMANUFACTURINGTOENABLESTORAGEANDDISTRIBUTIONTOCLINIC

RELATIONSHIPENGAGEMENT:

10-YEARSUPPLYAGREEMENT


21

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


Intelligent,Informed,PreciseBiologicMaterialsManagement

evo®ColdChain2.0™

Cloud-BasedColdChainManagement


TraditionalPharmaColdChain

80-130millionannualtemperaturesensitiveshipmentsrequiringcoldchainlogistics1

$15- $35billionspentannuallyreplacingproductslostduetotemperatureexcursions1

6%ofrevenuespentonlogistics2 yettheaverageperdoseexpenseforcoldchainisdeminimis

1ChainLinkResearch 2PharmaceuticalCommerce2016ColdChainSourcebook

$12billionspentannuallyoncoldchainlogistics

$9B

$3B

Specializedtertiarypackagingandinstrumentation

Transportation


CellTherapyColdChainDynamics

Reimbursementat$100K- >$500K

Fullyburdenedmanufacturingcostperdosecouldrangefrom

$30K- >$50KIndividualdosedelivery

failure

Significantperdose coldchain

expenseisrationalyetunappreciated

Celldeathfromtemperatureexcursionsintransit

Criticalrisks


25

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


PatentsPending

27

OurSolutionevo®ColdChain2.0™


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


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


biologistexJVRestructuring

• Allevo®SmartShipperandbiologistex™ColdChainSaaSIPandassetsnowconsolidatedinoneentitytoenableadditionalexternalinvestmentsintheJV;NotdependentonBioLifefunding

• BioLifeistheexclusivedistributortotheworldwideregenmedmarket• BioLifeholdsasignificantequitypositionandwillcontinuetoexclusivelymarket,sellandsupportcustomersintheregenmedspace

• 20%revenueshareforfirst3years


FinancialInformation


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


2017Catalysts• Celltherapycustomers,includingKitePharma,areexpectedtoreceiveregulatoryapprovalstocommencemarketingandcommercialmanufacturing,which,asaresult,shoulddriveincreaseddemandforourproprietarybiopreservationmediaproducts.

• ContinuedadoptionofCryoStor®andHypoThermosol®inpre-INDvalidationsandphase1,2and3clinicaltrialsofnewcellandtissuebasedproductsandtherapies.

• AdoptionoftheevoSmartShipperandColdChainManagementSaaSbyleadingCARTcelltherapycustomers.


2017Guidance• Biopreservationmediarevenuegrowthof20%- 25%over2016;revenueinexcessof $10million

• Grossmargininarangeof55%to60%• Operatingexpensesrangingfrom $8- $9million,reflectingaquarterlydecreaseof $400,000- $500,000 resultingfromtherestructuringofthebiologistexjointventure

• Restructureddebt• PositivequarterlyEBITDASbytheendof2017


OperatingLeverage• TwoindependentcGMPformulationandfillsuites

• 100,000literannualcapacityincurrentfacilities

• NosignificantCAPEXrequiredtorealize10Xcurrentproductionlevel

• Potential10+ percentagepointgrossmarginincreaseasdemandramps

• MinimalSG&Aexpenseincreasesneededtorealizefullproductionandmarginpotential


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


Options– 2.3M



SharePrice

© 2017 BIOLIFE SOLUTIONS, INC.38

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Volume Price

10YearSupplyAgreementPressReleaseIssued

NASDAQ:BLFS

Foradditionalquestionsorcomments,pleasecontact:

MikeRice|[email protected] |(425)686-6003

RoderickdeGreef|[email protected] |(425)686-6002

www.biolifesolutions.com

BioLifeSolutions,Inc.3303MonteVillaParkway,Suite310Bothell,WA98021


biolife solutions investor presentation march 2017

Health & Medicine