biodel, inc. investor presentation january 14, 2010

8/9/2019 Biodel, Inc. Investor Presentation January 14, 2010

1/39

nnua ea t care on erence

SanFranciscoJanuary 14,2010

BiodelInc.2010

www.biodel.com

0

28thAnnualHealthcareConference

SanFranciscoJanuary14,2010

The future of diabetes control


2/39


3/39

Company Overview Diabetes Focus Expertiseinmodifyingproteindeliveryandkinetics

-

market 5preclinicalandclinicalstageprograms

-

$4B+market- competitorsallconsideredequivalent

Fulllineofpresentations(vial,cartridgeforreusablepeninNDAanddisposablepenreadyforamendmentorsupplementin2010)

$54.6MMincashasof9/30/09

BiodelInc.2010www.biodel.com2




4/39


5/39

Insulin Market GrowthDriven By Innovative New Product Classes4,000

3,000

3,500

2,000

2,500

Rapid Acting

Regular Insulin

$MM

1,000

,

Proprietary Rapid Insulins3 X Price of RHI

Proprietary Rapid Insulins3 X Price of RHI

-

2004 2005 2006 2007 E 2008 F

3 X Price of RHIX Price of RHI





6/39

Insulin Market GrowthRapid Acting Insulin Market4,000

4,500 US&Europe ExFactory12 MonthMAY9/07 9/09 $MM

3,000

3,500

2,000

2,500 Novolog

Humalog

A idra

1,000

1,500

500





7/39

Physiologic Insulin PK and ReplacementBasal insulin covers glucose from liver(hepatic glucogenesis)Basal insulin covers glucose from liver(hepatic glucogenesis)

First Phase insulin release coversglucose from GI tract and signals liverto cease production of glucose(hepatic glucogenesis)

First Phase insulin release coversglucose from GI tract and signals liverto cease production of glucose(hepatic glucogenesis) ,Levemir

,Levemir

(hepatic glucogenesis)Rapidactinginsulineffort:Novolog,

HumalogandApidra

(hepatic glucogenesis)Rapidactinginsulineffort:Novolog,

HumalogandApidra

80

100

aIn

sulin

/m

l)

BoGlu

-140

20

40

60

Plasm(

coe(mgd)

-80

0

Meal Meal Meal

BiodelInc.2010www.biodel.com




8/39

Genetically Engineered AnalogsAnaloginsulin's havensulin s havemodified theprimarystructurei tising geneticengineering





9/39

VIAject Technology





10/39

VIAject TechnologyRemoval of zincvia EDTA de-stabilizes theh fexamer ofinsulin





11/39

VIAject TechnologyCit i iditric acidmasks surfacecharges anddestabilizes theHexamer ofInsulin





12/39

VIAject Technology In Subcutaneous SpaceNeutralized surface charges prevent insulin from re-aggregating under the skinestabilized hexamers rapidly disassociate and then neutralizeeutralized surface charges enhance absorption into bloodstream

Modifications Promotesmonomerizationofinsulin

Neutralizedsurfacechargesenhanceabsorptionintobloodstream

Preventsinsulinfromre-aggregatingundertheskin

RAPID AbsorptionAPID AbsorptionBiodelInc.2010www.biodel.com




13/39

Intellectual Property US and EuropeUnited Statesnited States Europeurope

TheUnitedStatesPatentand

TrademarkOfficeissuedU.S.PatentNo.7,279,457toBiodel

TheUnitedStatesPatentand

TrademarkOfficeissuedU.S.PatentNo.7,279,457toBiodel

OnOctober10th 2008theEuropean

PatentOfficenotifiedBiodelofintenttoissuepatent

OnOctober10th 2008theEuropean

PatentOfficenotifiedBiodelofintenttoissuepatent

ThepatentwillexpireJanuary2026 ThepatentwillexpireJanuary2026 ThepatentwillexpireMarch2025 ThepatentwillexpireMarch2025

Compositionofmatterpatents

ThesepatentsencompassVIAject andVIAtab

Compositionofmatterpatents

ThesepatentsencompassVIAject andVIAtab

Multipleadditionalpatentsfiledinternationally

AllIPinventedin-house

Multipleadditionalpatentsfiledinternationally

AllIPinventedin-house





14/39

How Humalog Differentiates In USPI





15/39

All 3 Commercial (or approved) Rapid-ActingInsulins Have Essentially the Same Profile





16/39

Phase 1Pharmacokinetic Profile100

12 IU Regular Human Insulin (Humulin R)2 IU VIAject 12U Lispro (Humalog)

708090

ma

30405060

%nunCm

0102030

00 10 20 30 40 50 60 70 80 90 100 110 120

Time (min)





17/39

Our Speed Advantage Alone May Be Sufficient ForSignificant Uptake

Perindependentmarketresearchendocrinologistsbelievethatafaster

mealtimeinsulinisneeded

Perindependentmarketresearchendocrinologistsbelievethatafaster

mealtimeinsulinisneeded

BiodelInc.2010

www.biodel.com16




18/39

VIAjectSignificant Advantages Over Current Therapiesis an Ultra Rapid Acting Insulin

Less Hyperglycemia

I dd

Faster absorption andfaster clearanceMore closely mimics

yp g y

Less VariabilityImprovedmprovedGlycemiclycemicControlontrol

More closely mimicsnormal first phase PK Better able to cover rapidf l f l

Less Hypoglycemiaonset of glucose from meal

May more consistentlyshuts off hepatic Less Weight Gain

pglucogenesis Improved MicrovascularFunction

BiodelInc.2010

www.biodel.com17




19/39

Phase 1Pharmacodynamic Profile12

min12 IU Humulin12 IU Humalog

8

10

Rmgkgm

12 IU Humalog12 IU VIAject

6

incoG

2

Be

0

0 1 2 3 4 5 6 7 8

BiodelInc.2010

www.biodel.com18




20/39

Phase 2 Meal StudyPharmacokinetics30

35

40

Early 1/2 Tmax (min)

120

140

160

Ins Tmax (min)

250

300

Late 1/2 Tmax (min)

0

5

1015

20

25

0

20

4060

80

100

0

50

100

150

PK-Parameters HumulinR Humalog VIAject p-value

a< 0.0001


a< 0.0001

Humulin Humalog Viaject Humulin Humalog Viaject Humulin Humalog Viaject


a< 0.0001


a< 0.0001

Early Tmax (min) 334 a, c 294b, c 131 a, b b< 0.0001c= n.s.

Ins Tmax (min) 13912a, c 638b, c 347a, ba< 0.001

b< 0.02



b< 0.02



b< 0.02



b< 0.02

c< 0.001

Late Tmax (min) 26716a, c 21720b, c 11812a, ba< 0.001

b< 0.001

c< 0.02

c< 0.001


b< 0.001

c< 0.02

c< 0.001


b< 0.001

c< 0.02

c< 0.001


b< 0.001

c< 0.02

BiodelInc.2010

www.biodel.com19




21/39

Phase 2 Meal Study Mean CurvesImproved Postprandial Glycemic Control180

Humulin R

16 Patients Average Blood Glucose

140

150

160

Humulin R

H l mgd)

110

120

130 HumalogVIAject

oGuoe(

70

80

90Meal

Bo

600 60 120 180 240 300 360 420

Time (min) Humulin R Humalog VIAject

BiodelInc.2010

www.biodel.com20




22/39

Endothelial Function and Microvascular StressFollowing Prandial Administration Type 2 Patients0.15

Humulin R

Asymetric Dimethyl Arginine (ADMA)Postprandial Change from Baseline

0.10

mo/)

*

*

Humulin RHumalogVIAject

0.05

DMA(mm

0.00

AD

*:p


23/39

Robust Phase 3 Study Designvs. Humulin R (per FDA EOP2)

Two open label studies Type 1 patients

Type 2 patientsype 2 patients

6 month duration Non-inferiority HbA1c Hypoglycemia

Weighteight Safety

BiodelInc.2010

www.biodel.com22

28thAnnualHealthcareConferenceSanFranciscoJanuary14,2010


24/39

Phase 3 Results March 2009 ConclusionsCompletedbothType1andType2studiesJuly2008

Type 1ype 1 + ReductioninSevereHypoglycemia + LessWeightGain - PainonInjectionbelieveduetolargervolumeofclinical25IUformulation sincereplacedbymoretolerable100IUpH7formulation

= HbA1ccontrolachievednoninferiorityafterexclusionofanomalousdatafromIndiaType 2ype 2 + Reductioninnon-SevereHypoglycemia + LessWeightGain - PainonIn ection believeduetolar ervolumeofclinical25IUformulation sincebeenreplacedby100IUpH7formulation

= HbA1ccontrolachievednoninferiority

BiodelInc.2010

www.biodel.com23



25/39

Successfully Bridged from 25 IU pH 4to 100 IU pH 7 Mitigating Tolerability Concern

=

Successfullymetprimaryendpoint

Areaundertheseruminsulinconcentrationcurveforthetimeinterval0-480min(AUC

INS0-480)and

Maximumseruminsulinconcentrationpost-dosing(CINS max)

BiodelInc.2010

www.biodel.com24



26/39

2009 VIAject NDA NDASubmissionDecember2009

AnticipatedPDUFAdateOctober30,2010

Pre-NDAmeetingwithFDAconfirmedstrategyofsubmissionwithexistingdata

, formulation

Disposablepenfinalized NDAtobesupplemented

NDAincludes:

10mLvial

3mLpencartridge

Re-usablepenreferencedinNDA

BiodelInc.2010

www.biodel.com25



27/39


28/39

Wockhardt UK to Supply Biodel With DisposableInsulin Pens and 3ml Cartridges SignedLOIwithWockhardtfordevelopmentandcommercialsupply

WockhardtsUKfacilityfills3mlcartridgesandassemblesdisposablepens

PendesignbasedonexistingWockhardtpenmarketedinIndia

MinorpendesignmodificationsmadeforUSandEuropeanmarkets

Disposablepenplannedtobeinsubsequentfiling

BiodelInc.2010

www.biodel.com27



29/39

Diabetes FocusPipeline Repositioning Rationale Leverageexistingin-houseexpertise&experience

Increasestrategicvalueofcompany

Allowcompanyandpotentialpartner(s)tobuilddiabetesfranchise

Low-riskinvestmentopportunitieswithshorttimelinetosi nificantste -u invalue

BiodelInc.2010

www.biodel.com28



30/39

Pipeline Reposition Diabetes Focus Oral

Sublingual

Insulin

Type2patients

Phase1VIAtab

ImprovedLantus

Adjustable

to

patients

needs

for

duration

Type1&2patientsAdjustable

505(b)(2)

AutomaticBasalInsulin Releasesproportionallytoglucoselevels

Pre clinical

505(b)(1) Excipient(s)notGRAS

SmartBasal

Type1&

2Patients

Preclinical

505(b)(2)

Stabilized

Glucagon

BiodelInc.2010

www.biodel.com29



31/39

VIAtab Developments Formulationadvance:freeze-driedcharge-maskedmonomer c nsu n

UndercurrentIND couldbeinpositiontoreenterclinic2010

BiodelInc.2010

www.biodel.com30



32/39

Adjustable Basal Insulin: Concept Variabilit acrossdoselevels

PROBLEM:

Variabilityacrosspatients

Cons stent24 our

durationis

difficult

to

achieveacrosspatients

ormu a onswou emar e e (short,mediumandlong)

Formulationscouldbemixedforfurthercustomization

Abasalinsulinwithadjustabledurationwould

Physicianrelies

on

CGM

or

MBG

diary

to

determineadjustmentrequired

personalizethe

insulin

to

apatientsspecificneeds

BiodelInc.2010

www.biodel.com31



33/39

Average Reduction in Duration of Lantus Activity with Biodel's ProprietaryGRAS Reduction Excipients In Patients with Type 1 Diabetes

Average Reduction in Lantus duration in Type 1Diabetics following addition of Biodel's

" "

30

35

ion

20

25

ctionindura

5

10

15

Percentred

0

6 1

Excipient units

BiodelInc.2010

www.biodel.com32



34/39

Smart Basal Insulin Basalinsulinthatreleasesproportionallytosubcutaneousglucoseconcentration

Automaticallyadjuststounanticipatedchangesinpatientsinsulinneeds(e.g.,exercise,fever,etc.)

505(b)(1):FullNDA,excipient(s)arenotGRAS

Type2takingonlybasalinsulin

-

Demonstratedproofofconceptindiabeticpigs

BiodelInc.2010

www.biodel.com33



35/39

Stable Injectable GlucagonPROBLEM:

Glucagonisveryunstable

rea - ownpro uc s ave er ngpo encyan con nue o

degrade Asaresultpotencyanddegradents changesunpredictably

OPPORTUNITY:

um era cou e w o s rea rom se

Caneventuallybedevelopedintoafullyfunctionalartificialpancreas(JDRF,J&J).

Addingtheglucagonbraketomatchtheinsulinaccelerator.

BiodelInc.2010

www.biodel.com34



36/39

Glucagon Market SegmentsMarketSegment Market Description UnmetNeed

RescueTherapy Emergencyusage productkepthandyforuseby3rd partyupon

Lyophilized productrequires

reconstitutionfromthirdpartyduring

severe ypoevent. pprox mate y

$100MM+inUS.

stress u severe ypoevent.

GIImaging Hypotonic agentusedinspecific GIradiological examinations.

Presentations availablearetoolarge

andleadtowastage costlyto

Approximately$50MMinUS. producelowdoselypho product.

Bihormonal Pump

Therapy

Theoreticalmarketutilizing glucagonas

a

brake

on

insulin

throughout

the

day

Glucagon istoounstabletoutilizein

pump

reservoirs

and

there

are

no

bi

insulinwithoutrunningtheriskofhypo.

Couldenableatrueclosedloopsystem.

andegg).

Mediated

Hypoglycemia

humanitarianreasons

and

to

support

criticalKOLendocrinologists

pancreatogenous hypoglycemiasyndromeandinsulinoma currently

havenoeffectivetreatment

BiodelInc.2010

www.biodel.com35



37/39

Glucagon Formulation at 37CGlucagon Formulation at 37C

80

on%

40

60

em

ainingGluca

BIOD-G-008

Control-Lilly

0

20

0 1 2 4 7 10 15

R

Time

BiodelInc.2010

www.biodel.com36



38/39

Financial Position9/30/09

SharesOutstanding 23.8MM

CashandInvestments($MM) $54.6MM

4th QuarterNetLoss $10.5MM

BiodelInc.2010

www.biodel.com37



39/39

Thank you

resen a ons ava a e a : www. o e .com

News and Events

Presentations and Publications

BiodelInc.2010

www.biodel.com38


biodel, inc. investor presentation january 14, 2010

Documents