Biodel, Inc. Investor Presentation January 14, 2010

28th A
Annual H lth
l Healthcare C f
Conference
San Francisco • January 14, 2010

© Biodel Inc. 2010
The future of diabetes control
28th Annual Healthcare Conference www.biodel.com
San Francisco • January 14, 2010 0

Forward Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements represent our management’s judgment regarding future events. All statements, other than
statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future
financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking
p , , p j , p p , p j g g
statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential,"
"predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying words. The company's forward-looking statements are
subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or
achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited
forward looking
to, our ability to have our VIAject® NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject® and our
other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market,
commercialize and achieve market acceptance for product candidates developed using our VIAdel® technology, particularly
VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our
clinical trials; the FDA’s findings regarding data anomalies observed in India in our Phase III clinical trial of VIAject® for
FDA s
patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon
the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration
arrangements for the commercialization of our product candidates and the success or failure of those collaborations after
consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our
commercialization,
commercialization marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating
losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our filings
with the Securities and Exchange Commission. The company disclaims any obligation to update any forward-looking
statements as a result of events occurring after the date of this press release.

© Biodel Inc. 2010

Company Overview – Diabetes Focus
■ Expertise in modifying protein delivery and kinetics

■ Now entirely focused on multi-billion dollar enhanced insulin and diabetes
multi billion
market – 5 preclinical and clinical stage programs

■ PDUFA 2010 product: VIAject® an ultra rapid acting prandial insulin
rapid-acting
 $4B+ market - competitors all considered equivalent
 Best in class profile
 Full line of presentations (vial, cartridge for reusable pen in NDA and
disposable pen ready for amendment or supplement in 2010)

■ $54.6MM in cash as of 9/30/09

© Biodel Inc. 2010

Pipeline - Diabetes Focus
Pre Clinical Phase I Phase II Phase III Approval

®
Injectable prandial insulin - 505(b)(2) PDUFA ’10

Oral sublingual prandial insulin - 505(b)(2)

BIOD-Adjustable Basal
Diabetes
Injectable adjustable basal insulin - 505(b)(2)

BIOD-Smart Basal

Injectable smart basal insulin - 505(b)(1) NCE

BIOD-Stable
BIOD Stable Glucagon

Injectable stable glucagon - 505(b)(2)

All product candidates invented in-house on VIAdel™ proprietary technology
p p p y gy

© Biodel Inc. 2010

Insulin Market Growth
Driven By Innovative New Product Classes

4,000

3,500

3,000

2,500
2 00
$ MM

Rapid Acting
2,000
Regular Insulin
1,500
1 500

1,000
Proprietary Rapid Insulins
500 3 X Price of RHI
-
2004 2005 2006 2007 E 2008 F

© Biodel Inc. 2010

Insulin Market Growth
Rapid Acting Insulin Market
4,500 US & Europe Ex Factory 12 Month MAY 9/07 ‐ 9/09 $MM
4,000

3,500

3,000

2,500 Novolog
2,000 Humalog
Apidra
1,500

1,000

500

‐
2007 2008 2009

© Biodel Inc. 2010

Physiologic Insulin PK and Replacement
First Phase insulin release covers
Basal insulin covers glucose from liver glucose from GI tract and signals liver
(hepatic glucogenesis) to cease production of glucose
Long acting insulin effort: Lantus,
Lantus (hepatic glucogenesis)
Levemir Rapid acting insulin effort: Novolog,
Humalog and Apidra

120

Blood Gluc
100
Plasm Insulin
U/ml)

80
-140
ma
(µU

cose (mg/dl)
60
-80
40
20
0

Meal Meal Meal
Time
© Biodel Inc. 2010

Genetically Engineered Analogs

Analog
insulin s
insulin's have
modified the
primary
structure
using genetic
i ti
engineering

© Biodel Inc. 2010

VIAject ® Technology

© Biodel Inc. 2010


Removal of zinc
via EDTA de-
stabilizes the
hexamer of
h f
insulin

© Biodel Inc. 2010


Citric id
Cit i acid
masks surface
charges and
destabilizes the
Hexamer of
Insulin

© Biodel Inc. 2010

VIAject® Technology In Subcutaneous Space
Neutralized surface charges prevent insulin from re-aggregating under the skin
Neutralized surface charges enhance absorption into bloodstream
Destabilized hexamers rapidly disassociate and then neutralize

Modifications
 Promotes monomerization of insulin
 Neutralized surface charges enhance absorption into bloodstream
 Prevents insulin from re-aggregating under the skin

RAPID Absorption
© Biodel Inc. 2010

Intellectual Property – US and Europe

United States Europe

■ The United States Patent and ■ On October 10th 2008 the European
Trademark Office issued U.S. Patent Office notified Biodel of
Patent No. 7,279,457 to Biodel® intent to issue patent

■ The patent will expire January 2026 ■ The patent will expire March 2025

■ Composition of matter patents

■ These patents encompass VIAject® and VIAtab®

■ Multiple additional patents filed internationally

■ All IP invented in-house

© Biodel Inc. 2010

How Humalog ® Differentiates In USPI

© Biodel Inc. 2010

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

© Biodel Inc. 2010

Phase 1
Pharmacokinetic Profile
12 IU VIAject® 12U Lispro (Humalog®) 12 IU Regular Human Insulin (Humulin® R)

100
90
80
70
max
% Insulin Cm

60
50
40
30
20
10
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (min)

© Biodel Inc. 2010

Our Speed Advantage Alone May Be Sufficient For
Significant Uptake

Per independent market research
endocrinologists believe that a faster
meal time insulin is needed

© Biodel Inc. 2010

VIAject®
Significant Advantages Over Current Therapies
®
is an Ultra Rapid Acting Insulin
 Less Hyperglycemia
yp g y
 Faster absorption and
faster clearance
 Less Variability
 More closely mimics Improved
I d
normal first phase PK Glycemic
Control  Less Hypoglycemia
 Better able to cover rapid
onset of glucose from meal
f l f l
 Less Weight Gain
 May more consistently
p
shuts off hepatic
glucogenesis  Improved Microvascular
Function

© Biodel Inc. 2010

Phase 1
Pharmacodynamic Profile

12 12 IU Humulin®
min.

12 IU Humalog®
Baseline corr. GIR mg/kg/m

10

12 IU VIAject®
8

6

4

2

0
0 1 2 3 4 5 6 7 8

© Biodel Inc. 2010

Phase 2 Meal Study
Pharmacokinetics
Early 1/2 Tmax (min) Ins Tmax (min) Late 1/2 Tmax (min)
40 160 300
35 140 250
30 120
25 100 200
20 80 150
15 60 100
10 40
5 20 50
0 0 0
Humulin®
H li ® Humalog®
H l ® Viaject®
Vi j ® Humulin®
H li ® Humalog®
H l ® Viaject®
Vi j ® Humulin®
H li ® Humalog®
H l ® Viaject®
Vi j ®

PK-Parameters Humulin® R Humalog® VIAject® p-value
a < 0.0001
Early ½ Tmax (min) 33±4 a, c 29±4 b, c 13±1 a, b b < 0.0001
c = n.s.
a < 0.001
Ins Tmax (min) 139±12 a, c 63±8 b, c 34±7 a, b b < 0.02
c < 0.001
a < 0.001
Late ½ Tmax (min) 267±16 a, c 217±20 b, c 118±12 a, b b < 0.001
c < 0.02

© Biodel Inc. 2010

Phase 2 Meal Study Mean Curves
Improved Postprandial Glycemic Control
16 Patients Average Blood Glucose

180
170 Humulin® R
160
Bloo Glucose (mg/dl)

150
140
Humalog®
H l
(

130
120
VIAject®
110
od

100
90
Meal
80
70
60
0 60 120 180 240 300 360 420

Time (min) Humulin® R Humalog® VIAject ®

© Biodel Inc. 2010

Endothelial Function and Microvascular Stress
Following Prandial Administration – Type 2 Patients
Asymetric Dimethyl Arginine (ADMA)
0.15 Postprandial Change from Baseline
Humulin® R
*
0.10 * Humalog®
mol/l)

VIAject®
DMA (mm

0.05
AD

0.00

*: p< 0.05 vs. VIAject®

-0.05

Asymetric Dimethyl Arginine: A biochemical marker of oxidative stress

© Biodel Inc. 2010

Robust Phase 3 Study Design
®
vs. Humulin® R (per FDA EOP2)

■ Two open label studies
 Type 1 patients
 Type 2 patients

■ 6 month duration
 Non-inferiority HbA1c
 Hypoglycemia
 Weight
 Safety

© Biodel Inc. 2010

Phase 3 Results – March 2009 Conclusions
Completed both Type 1 and Type 2 studies July 2008

Type 1
■ + Reduction in Severe Hypoglycemia
■ + Less Weight Gain
■ - Pain on Injection believe due to larger volume of clinical 25IU formulation
■ since replaced by more tolerable 100IU pH7 formulation
■ = HbA1c control achieved non inferiority after exclusion of anomalous data from India

Type 2
■ + Reduction in non-Severe Hypoglycemia
■ + Less Weight Gain
■ - Pain on Injection believe due to larger volume of clinical 25IU formulation
j g
■ since been replaced by 100IU pH7 formulation
■ = HbA1c control achieved non inferiority

© Biodel Inc. 2010

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

 Reduced volume and acidity = improved tolerability

 Successfully met primary endpoint
 Area under the serum insulin concentration curve for the time interval
0-480 min (AUCINS0-480) and
 Maximum serum insulin concentration post-dosing (CINS max)

© Biodel Inc. 2010

2009 VIAject® NDA
■ NDA Submission December 2009

■ Anticipated PDUFA date October 30, 2010
 Pre-NDA meeting with FDA confirmed strategy of submission with
existing data
 Bridged to more convenient, tolerable and stable 100 IU pH 7 liquid
formulation
 Disposable pen finalized – NDA to be supplemented

■ NDA includes:
 10 mL vial
 3 mL pen cartridge
 Re-usable pen referenced in NDA

© Biodel Inc. 2010

Recent VIAject ® Developments
■ Microvascular study demonstrated the advantages of VIAject’s® PK/PD
profile on markers of endothelial and microvascular function

■ Market research indicates strong physician interest based on current
product profile (different mechanism of rapid absorption, existing clinical
results versus lispro and RHI)

■ CGM pump trial Q1 2010

 Subjects: Type 1 pump patients

 Primary outcome measure: Glycemic variability (time in euglycemia)

 Pre-specified secondary outcome measure: non-inferiority on HbA1c

© Biodel Inc. 2010

Wockhardt UK to Supply Biodel With Disposable
Insulin Pens and 3ml Cartridges
■ Signed LOI with Wockhardt for development and commercial supply

■ Wockhardt’s UK facility fills 3ml cartridges and assembles disposable
pens

■ Pen design based on existing Wockhardt pen marketed in India

■ Minor pen design modifications made for US and European markets

■ Disposable pen planned to be in subsequent filing

© Biodel Inc. 2010

Diabetes Focus
Pipeline Repositioning Rationale

■ Leverage existing in-house expertise & experience

■ Increase strategic value of company

■ Allow company and potential partner(s) to build
diabetes franchise

■ Low-risk investment opportunities with short
timeline to significant step-up in value
g p p

© Biodel Inc. 2010

Pipeline Reposition – Diabetes Focus
• Oral Sublingual Insulin
• Type 2 patients
VIAtab™
• Phase 1
• 505(b)(2)
• Improved Lantus – Adjustable to patients’ needs for duration
Adjustable • Type 1 &2 patients
Basal • Phase 1
Phase 1
• 505(b)(2)
• Automatic Basal Insulin – Releases proportionally to glucose levels
• Type 1 & 2 patients
Type 1 & 2 patients
Smart Basal
• Pre ‐clinical
• 505(b)(1) – Excipient(s) not GRAS
• For Rescue & Bi‐hormonal Pump
For Rescue & Bi hormonal Pump
Stabilized • Type 1 & 2 Patients
Glucagon • Pre‐clinical
• 505(b)(2)

© Biodel Inc. 2010

VIAtab ™ Developments

■ Formulation advance: freeze-dried charge-masked
monomeric i
i insulin
li

■ Simulates first phase insulin release

■ Under current IND – could be in position to reenter
clinic 2010

© Biodel Inc. 2010

Adjustable Basal Insulin: Concept

PROBLEM:
• Variability across dose levels
y
Consistent 24 hour
C i 2 h
duration is difficult to
achieve across patients • Variability across patients

SOLUTION: •3f
3 formulations would be marketed
l ti ld b k t d
A basal insulin with (short, medium and long)
adjustable duration would • Formulations could be mixed for further
allow physicians to
allow physicians to customization
personalize the insulin to • Physician relies on CGM or MBG diary to
determine adjustment required
a patient’s specific needs

© Biodel Inc. 2010

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

Average Reduction in Lantus duration in Type 1
Diabetics following addition of Biodel's
proprietary GRAS "reduction " excipients
reduction
35

30
tion
uction in durat

25

20
Percent redu

15
1

10

5

0
6 1

Excipient units

© Biodel Inc. 2010

Smart Basal Insulin
■ Basal insulin that releases proportionally to
subcutaneous glucose concentration

■ Automatically adjusts to unanticipated changes in
patient’s insulin needs(e.g., exercise, fever, etc.)

■ 505(b)(1): Full NDA, excipient(s) are not GRAS

■ Basal insulin of choice for patients with:
 Type 2 taking only basal insulin
 Type 1 or Type 2 treated with basal-bolus regimens
basal bolus

■ Demonstrated proof of concept in diabetic pigs
© Biodel Inc. 2010

Stable Injectable Glucagon
PROBLEM:
■ Glucagon is very unstable
■ B kd
Break-down products h
d t have diff i potency and continue to
differing t d ti t
degrade
■ As a result potency and degradents changes unpredictably

OPPORTUNITY:
■ Pump therapy coupled with CGM holds great promise
■ Can eventually be developed into a fully functional artificial
pancreas (JDRF, J&J).
■ Adding the “glucagon brake” to match the “insulin accelerator.”

© Biodel Inc. 2010

Glucagon Market Segments
Market Segment Market Description Unmet Need
Rescue Therapy Emergency usage – product kept Lyophilized product requires
“handy” for use by 3rd party upon reconstitution from third party during
severe hypo event.  Approximately
h A i l stressful severe hypo event.
f l h
$100MM+ in US.
GI Imaging Hypotonic agent used in specific GI Presentations available are too large
radiological examinations.
g and lead to wastage – costly to
g y
Approximately $50MM in US. produce low dose lypho product.
Bi hormonal Pump Theoretical market utilizing glucagon as Glucagon is too unstable to utilize in
Therapy a “brake” on insulin throughout the day pump reservoirs and there are no bi
to allow more aggressive usage of
to allow more aggressive usage of hormonal pumps available (chicken
hormonal pumps available (chicken
insulin without running the risk of hypo. and egg).
Could enable a true closed loop system.

Intractable Insulin
Intractable Insulin Orphan indications   pursue for
Orphan indications ‐ pursue for Diseases such as noninsulinoma
such as noninsulinoma
Mediated humanitarian reasons  and to support pancreatogenous hypoglycemia
Hypoglycemia critical KOL endocrinologists syndrome and insulinoma currently
have no effective treatment

© Biodel Inc. 2010

Glucagon Formulation at 37C

Glucagon Formulation at 37C
100

80
Remaining Glucag %
gon

60

BIOD-G-008
40
Control-Lilly
R

20

0
0 1 2 4 7 10 15
Time

© Biodel Inc. 2010

Financial Position

9 30 09
9/30/09

Shares Outstanding 23.8 MM

Cash and Investments ($MM) $54.6 MM

4th Quarter Net Loss $10.5 MM

© Biodel Inc. 2010

®

Thank you

Presentations available at:
P t ti il bl t www.biodel.com
bi d l
• News and Events
• Presentations and Publications

© Biodel Inc. 2010

Biodel, Inc. Investor Presentation January 14, 2010

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Biodel, Inc. Investor Presentation January 14, 2010