Presentation, dated April 2, 2009

Future Leaders in the Biotech Industry

April 2, 2009

Dr. Mark A. Sirgo

President & Chief Executive Officer

NASDAQ: BDSI

Exhibit 99.1

Notice Regarding Forward Looking Statements

Certain statements contained in this presentation or in other documents of BioDelivery Sciences International, Inc. (the

“Company”), along with certain statements that may be made by management of the Company orally in presenting this

material, may contain “ forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.

These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words

such as "estimate," "expect," "intend," "believe," "plan," "anticipate," “projected” and other words and terms of similar

meaning in connection with any discussion of future operating or financial performance or condition. These statements

are based upon the current beliefs and expectations of the Company's management and are subject to significant risks

and uncertainties. Statements regarding future action, future performance and/or future results, including, without

limitation, actual sales results, if any, or the timing for completion and results of scheduled or additional clinical trials and

FDA review of the Company's formulations and products, may differ from those set forth in the forward-looking

statements. Peak sales and market size estimates have been determined on the basis of market research and

comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all, or that such

market size estimates will prove accurate.

Because actual results are affected by these and other potential risks, contingencies and uncertainties, the Company

cautions investors that actual results may differ materially from those expressed or implied in any forward-looking

statement. It is not possible to predict or identify all such risks, contingencies and uncertainties. The Company identifies

some of these factors in its Securities and Exchange Commission (“SEC”) filings on Forms 10-K, 10-Q and 8-K, and

investors are advised to consult the Company’s filings for a more complete listing of risk factors, contingencies and

uncertainties effecting the Company and its business and financial performance.

The Company assumes no obligation to update forward-looking statements as circumstances change. Investors are

advised to consult further disclosures that the Company makes or has made on related subjects in the Company's Form

10-K, 10-Q and 8-K reports.

In presenting this material or responding to inquiries in connection with a presentation, management may refer to results,

projections or performance measures that are not prepared in accordance with U.S. Generally Accepted Accounting

Principles (“GAAP”) as reported in the Company’s SEC filings. These results, projections or performance measures are

Non-GAAP measures and are not intended to replace or as a substitute for results measured under GAAP,

but rather as supplement to the GAAP reported results.

Corporate Highlights

SPECIALTY PHARMACEUTICAL COMPANY

–

Leverage novel proprietary patent-protected drug delivery technologies to rapidly advance the

commercialization of new applications of proven therapeutics to address unmet market needs

HIGH ROI DRUG DEVELOPMENT PLATFORM

–

Utilize the 505 (b)(2) regulatory process to bring products to market faster, with less risk, and at

lower costs resulting in higher return on investment

FOCUSED COMMERCIAL APPROACH

–

Commercial focus on products targeting conditions common to surgical and oncology patients

such

pain

and

infections-

narrow

marketing

channel

with

large

sales

opportunities

COMPELLING BILLION DOLLAR PORTFOLIO PROJECTED

–

Near-term

product

opportunity:

ONSOLIS

™

(BEMA

™

Fentanyl),

2009

approval

anticipated;

>$200 million peak sales potential, Strong global marketing partner

–

Medium-term

portfolio:

BEMA

™

Buprenorphine

(Phase

2),

Bioral

™

Amphotericin

(Phase

STRONG FINANCIALS

–

Debt;

$30

million*

upon

ONSOLIS

™

approval

and

launch;

double

digit

royalty

* Includes $3.0 million advance received January 2009 ($26.9 million due at approval and launch)

Key Value Driver: 1H 2009 Approval of ONSOLIS™

Anticipated For Breakthrough Cancer Pain

August 28, 2008: received a Complete Response Letter

ONSOLIS™

Complete Response Content:

–

Conversion of risk minimization action plan (“RiskMAP”) to a

risk evaluation mitigation strategy (“REMS”)

–

No other deficiencies noted, including chemistry, manufacturing

and controls, nonclinical, or clinical efficacy/safety.

FDA meeting held November 17 to review draft REMS

Resubmission completed December 2008

–

FDA action date is June 2009

Transmucosal

Fentanyl

Drug Delivery Technologies

Competitive Landscape

Transmucosal Fentanyl Delivery Systems

Actiq

(1996)

Fentora

(2006)

Formulation:

Buccal

tablet

Administration:

Place

between

cheek

and gums above a molar. Allow to

dissolve. After 30 minutes, if remnants

still remain, swallow with a glass of water.

Formulation:

Oral

transmucosal

lozenge

Administration:

Place

between

cheeks

and gums and actively suck while moving

around the mouth.

ONSOLIS

™

Formulation:

Buccal

soluble

film

Administration:

Place

inside

mouth

inner cheek. Hold for 5 seconds.

Dissolves within 15-30 minutes.

BEMA

™

(BioErodible

MucoAdhesive)

Film

Technology

Bi-layered film technology

Active drug in the muco-

adhesive layer

Backing layer facilitates

unidirectional flow of drug

Adheres to oral mucosa in < 5

seconds

Dissolves within 15-30

minutes

Designed to optimize delivery

across the mucosa

BEMA

attributes:

Convenient

Easy

use

Good

oral

tolerability

clinical

studies

Cannot

crushed

snorted

ONSOLIS

™

Profile and Attributes

0.0

0.5

1.0

1.5

2.0

Time After Dose Administration (hours)

0.0

0.5

1.0

1.5

2.0

Greater and More Rapid Absorption of Fentanyl

Compared to Actiq

in this PK Study

40% Greater Absorption versus Actiq®

ONSOLIS™

The

mean

peak

concentration

was

higher

after

ONSOLIS™

than

Actiq®

The

median

Tmax

was

shorter

ONSOLIS™

hour)

than

Actiq®

hours)

Plasma

Concentrations

–

800

mcg

doses*

Vasisht, et al. American Academy of Pain Medicine, Poster Presentation, February 2008.

ONSOLIS

™:

Dose Proportionality Across Dose Range

Dose Proportionality Demonstrated Based on Linear Pharmacokinetics

0.0

0.5

1.0

1.5

2.0

2.5

Time (hr)

1200 µg

600 µg

200 µg

ONSOLIS Plasma Fentanyl Concentrations

Vasisht,

al.

American

Pain

Society,

Poster

Presentation,

May

2008.

ONSOLIS

™

Attributes

Thin Film

(simple placement)

Convenient, Easy to use

“Adheres –

Delivers -

Dissolves”

2.0%

Good Oral Tolerability

Incidence of drug-related application site AEs

Discontinued due to application site AEs

200 –

1200 mcgs

Provides linear pharmacokinetics across full

dose range

Dose range

Effective dose not found

* % patients in FEN-201 and FEN-202 Phase 3 clinical studies

ONSOLIS

™

Market Opportunity

1200

800

500

200

400

600

800

1000

1200

Cancer Patients

CA + Pain

BTP

Significant Market Opportunity –

Breakthrough Cancer Pain

Current/Future Market Size:

US cancer breakthrough pain market:

Branded Drugs -

sales estimated to grow

from

$400

mln

~$1.3

bln

2017

Current

Market

Leaders

Fentora

™

: $182 million

Actiq

/Generics: $562 million

ONSOLIS Expectations:

Peak sales potential >$200 million

Source:

Datamonitor,

Commercial

Pipeline

Insights

–

Opioids;

March

2008

Wolters

Klewer, 2008 sales

Source: Data Monitor

(US Data Only-calculations based on one year incidence,

actual numbers will be higher due to survival beyond one

year)

<20,000 patients

being treated for

cancer BTP

ONSOLIS

™

Commercial Partner

ONSOLIS

™

Global Commercialization Partner*: MEDA AB

Intl specialty pharma

based in Sweden

2,500 employees/1,650 com ops

Sales: 2001 -

2007: $30M $1.3B

Significant US presence via MedPointe

(Carter Wallace) acquisition in 2007

Therapeutic expertise includes

pain/inflammation (Soma

, tramadol,

NSAIDs) and respiratory (Astellin

)

Global partner –

pain experience

ONSOLIS™

priority

worldwide

Primary detailing position -

2 yrs

Over 400 US sales reps; coverage

of pain specialists

* Licnesing

agreement does not include Taiwan and South Korea

ONSOLIS

™

Represents a Significant Financial

Opportunity for BDSI

Financial Benefits to BDSI

$30 million upon NDA approval and commercial launch*

$30 million for achievement of specified sales milestones

Significant double digit royalty

Meda covers all future development costs for ONSOLIS including REMS

program; Phase IIIB-IV and Non-Cancer Breakthrough Pain program

Peak Forecast Sales in excess of $200 million**

Anders Lonner, CEO of Meda AB, stated “BEMA Fentanyl represents a huge

opportunity for us in the U.S. Our ambition with this product within the

breakthrough cancer pain in opioid tolerant patients indication is to reach well

over $200 million in yearly sales.”

* Includes advance received January 2009.

** BDSI estimate

Capital Efficient Business Model

ONSOLIS

™

–

Early and significant return on investment

<$25M

Total Costs

3 Years

Timeline to NDA

Product Development

* Approval anticipated 1H09

Medium-Term Product Portfolio

BEMA

™

Buprenorphine: Schedule III Narcotic

BDSI’s

Entry Into Broader Pain Market

Market Need

Rapidly escalating problem of opioid abuse and

addiction in the US

Short and long-term side effect issues with opioids

Safety issues with COX-2 inhibitors and NSAIDS

Development

Goals

Initial indication: Post-operative pain using 505(b)(2)

Follow-on indication: Chronic pain (back Pain,

osteoarthritis, etc.) –

moderate to severe.

Market

Opportunity

Peak Forecast Sales Potential >$500 million *

* BDSI estimate

Potential

Attributes

Lower abuse and addiction potential

Lower incidence of opioid side effects

Once daily dosing

BEMA

™

Buprenorphine Provides a Potential

Alternative to CII Drugs

NSAID, COX-2

Weak opioid

Severe

Pain:

Strong

opioid

Pain

persisting or

increasing

Pain

persisting or

increasing

Acute Pain:

•

Post operative

•

Musculoskeletal injuries

•

Acute low back pain

Fentanyl

Morphine

OxyContin

BEMA

™

Buprenorphine

Tramadol

COX-2’s

Naproxen

Acetaminophen

Delay CII opioid use

OxyContin is a registered trademark of Purdue Pharma.

Moderate

Pain:

Mild

Pain:

BEMA Buprenorphine Provides a Potential

Alternative to CII Drugs

Mild Pain: non-opioid

Pain

persisting or

increasing

Pain

persisting or

increasing

OxyContin

Duragesic

Kadian/Avinza

Chronic Pain Indications:

•Back Pain

•Osteoarthritis

BEMA

™

Buprenorphine

Tramadol

Vicodin

COX-2’s

Naproxen

Ibuprofen

Delay CII opioid use

OxyContin

is a registered trademark of Purdue Pharma.

Duragesic

is a registered trademark of Johnson & Johnson

Avinza

is a registered trademark of King Pharmaceuticals

Kadian

is a registered trademark of Actavis

Severe Pain: strong opioid

non-opioid

Moderate

Pain:

weak

opioid

non-opioid

Moderate to Severe Pain Market Accounts for

Over 50% of Units Sold

Source: Wolters Kluwer Integrated Pharmaceutical Audits. Mild = APAP, salicylate, NSAIDs/COXII, Moderate to severe =

hydrocodone, propoxyphene, codeine & combination, Severe = morphine, oxycodone, fentanyl, methadone

Segment Value

of approximately

$4–5 Billion

Integrated Units (Millions)

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

24,000

26,000

2004

2005

2006

2007

Severe

Mod to

Sev

Mild

BEMA Buprenorphine

will compete for this

market segment

>50% of units

BEMA

™

Buprenorphine:

Initial Formulation Pharmacokinetics

0.2

0.4

0.6

0.8

1.2

1.4

1.6

Hours

Suboxone

BEMA™

Buprenorphine

Initial Formulation 2 mg

BEMA

™

Buprenorphine

PK/PD

Study

–

BEMA

Buprenorphine

Provides Rapid and High Blood Plasma Concentrations

Suboxone

2 mg

BEMA™

Buprenorphine

Initial Formulation 2 mg

BEMA™

Buprenorphine

NEW Formulation 1 mg

Hours

0.2

0.4

0.6

0.8

1.2

1.4

1.6

1H 2012 / 1H 2013

NDA Submission/

Approval

Phase 3

Phase 2

BEMA™

Buprenorphine Development Timeline

1H 2011 / 1H 2012

Bunionectomy; Pre-

hip/knee replacement

surgery

Planned for 1Q 2010

Dental pain study

Planned for 2Q 2009

NSAID-resistant

Osteoarthritis

Planned for 4Q 2010

N/A

Chronic

Acute

BEMA™

Buprenorphine: Market Positioning

First Target: moderate to severe acute

pain

–

Post-operative

–

Musculoskeletal

Second Target: moderate to severe chronic

pain

–

Lower Back

–

Osteoarthritis

BEMA™

Buprenorphine can potentially generate sales of over

$500 million* with a share of only ~10% of the moderate-severe

pain market segment

*BDSI estimate

Narcotic of choice in patients requiring

acute

chronic

pain

treatment

stepping

from

NSAIDs or other non narcotic analgesics

Bioral

™

Drug Delivery Technology

Oral Delivery

Bioral™

Amphotericin B:

Potential First Oral Fungicidal

Market Need

Drug resistance to existing oral “fungistatic”

agents leads to hospitalization and IV

amphotericin B treatment

No orally available agents

Development

Goals

First oral fungicidal agent; Potential to prevent

hospitalizations and/or facilitate earlier patient

discharge

Treatment of esophageal candidiasis

Improved tolerability

Market

Opportunity

Peak Forecast Sales >$400 million *

* BDSI estimate

Development

Support

Cooperative R&D agreement (CRADA) with

Walter Reed Army Institute for Research

(WRAIR): Leishmaniasis

Drugs for Neglected Disease initiative (DNDi) –

clinical program for neglected parasitic diseases

Phase 1 Study Results -

Bioral

™

Amphotericin B

Hours

200 mg

400 mg

800 mg

•

Bioral

™

Amphotericin

was

well-tolerated

single

oral

doses

200

400

•

Plasma

concentrations

Amphotericin

are

comparable

prior

results

from

animal studies

Abstract

presented

the

Focus

Fungal

Infections

Meeting,

March

2009

Phase 3

Phase 2

Esophageal Candidiasis: Planned for 2011

Leishmaniasis 2010 (DNDi, WRAIR)*

Single dose pharmacokinetics completed

4Q 2008

Multi-dose pharmacokinetic study 2Q 2009

Phase 1

Bioral™

Amphotericin B Development Timeline*

* Research and development partnership with Drugs for Neglected Diseases initiative

(DNDi) and Walter Reed Army Institute for Research.

Pre-clinical

Phase I

Phase II

Phase III

NDA Filed

Marketed

Product

ONSOLIS™

(fentanyl

buccal

soluble

film)

Breakthrough Cancer Pain**

BEMA™

Buprenorphine

Moderate to Severe Pain

Bioral

™

Amphotericin B

Fungal Infections

>$200 million*

$500 million+*

$400 Million*

* peak sales potential, BDSI estimate

** Opioid tolerant patients

Product Portfolio Summary

= Anticipated in 2009

2009 Financial Highlights

ONSOLIS

™

NDA Approval & Launch

Royalty

Sales

ONSOLIS

™

Cash Flow Positive From Operations

$30.0 Million*

Double-digit

> $30 Million Potential

Includes $3.0 million advance received January 2009

Investor Highlights: BDSI*

Near-Term Product Opportunity:

ONSOLIS

™

(BEMA

™

Fentanyl)

approval anticipated in 1H 2009, Strong

Commercial Partner making ONSOLIS

™

#1 Global Priority

Medium-Term Product Potential

(BEMA

™

Buprenorphine, Bioral

™

Amphotericin B) = Revenue

Growth Potential

2009 Key Financials:

–

Debt free

–

> $30 Million Revenue Potential and cash flow positive 2009**

* Market cap (03/30/09): $63 million based on 19.2 million shares outstanding at $3.30

** Includes $3.0 million advance received January 2009