bdsi investor presentation

2021 Corporate Presentation I 1

Corporate Presentation

August 2021Nasdaq: BDSI


CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTSThis presentation and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among or things, certain“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements mayinclude, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,”“would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’smanagement and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results including, without limitation, theexpectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021, the acquisition and launch of ELYXYB and growth in neurology, may differmaterially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors(many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcarefacilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2020 annual report on Form 10-K filed with the US Securities and Exchange Commission andsubsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required byapplicable law.

Non-GAAP Financial MeasuresThis presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented byother companies.

Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, non-cash amortization of intangible assets, andthe financial impact of certain one-time items that are non-recurring, including the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition in Q2 2020.

EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes and depreciation and amortization.

The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of theCompany's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanyingreconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly,should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.

A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in the appendix of this presentation.

Forward Looking Statement


Strong Product Momentum

• Significant year over year growth in TRxs

• Continued success utilizing digital tools with in-person engagements increasing

• Focused on clinically differentiated products addressing unmet needs

• Strong formulary coverage for BELBUCA and Symproic

Solid Business FundamentalsWell-Positioned for Future

Strategy

Acquisition of ELYXYB expands BDSI’s Growth Platform into Neurology:

• Highly attractive opportunity to diversify our product portfolio

• FDA Approved, Commercially Ready Asset

• Q1 2022 Launch Planned

Rapidly Growing Commercial-Stage Specialty Pharma Company


Leadership Team with Commercial & Strategic ExperienceExceptional Team with Outstanding Record of Execution and a Strategic Focus on Growth

Jeff BaileyCEO

Scott PleshaPresident & Chief Commercial Officer

Terry CoelhoExecutive Vice President & CFO


High Prevalence & Quality-of-Life Impact

Long-acting Opioids (LAO) Remains a Large Prescription Market**

Significant Unmet Need in Chronic PainRepresents Large Potential Market

1. *Chronic pain limiting life or work activities on most days or every day in the past 6 months. 2. **SAO use measured as opioid prescriptions of duration 3 days or fewer. LAO use measured as prescriptions for ER/LA opioid formulations.

1CDC’s analysis of 2016 National Health Interview Survey (NHIS) data. 2 Source: Symphony Metys Data, & Symphony Vantage Application (Retail, Mail Order & LTC Data)

1 IN 5 US ADULTSsuffers from chronic pain1

19.6 MILLIONAdults report high-impact chronic pain*1

$2.9 BILLIONTotal annual LAO sales in 20202

10.8 MILLIONPrescriptions written for long-acting opioids in 20202


Multiple refills allowed without a new prescription

Ability for physicians to prescribe via telehealth

Proven efficacy

Placebo like tolerability in clinical trials*

Respiratory ceiling effect

Range of 7 dose strengths

BELBUCAPhysicians Attracted by BELBUCA’s Efficacy and Safety in Managing Chronic Pain

*Package insert1. Source: Symphony Metys

BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate

230k+ patients and 22k+ prescribers to date1

BELBUCA’s classification as a Schedule III drug allows for strategic advantages over other Schedule II opioids

BELBUCA patent exclusivity through January 2027


Significant YoY Growth in BELBUCA TRx VolumeBELBUCA Achieved All-Time High TRx Market Share

Source: Symphony Metys Data, & Symphony Vantage Application (Retail, Mail Order & LTC Data) *Long-Acting Opioid

Growth Metrics

+11% Q2 2021 vs Q2 2020

+5% Q2 2021 vs Q1 2021

Growing BELBUCA’s TRx Market Share through effective execution

and marketing support

0.0%0.5%1.0%1.5%2.0%2.5%3.0%3.5%4.0%4.5%5.0%

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

Q3 '17Q4 '17Q1 '18Q2 '18Q3 '18Q4 '18Q1 '19Q2 '19Q3 '19Q4 '19Q1 '20Q2 '20Q3 '20Q4 '20Q1 '21Q2 '21

TRx Volume LAO* Market Share

TRx share increased by 24% YoY to 4.7% of the LAO market in Q2 2021

• Total Rx share increasing due to broader adoption by Healthcare Professionals

BELBUCA


7.2% 7.4%7.8%

6.7%

7.7%

3.8%4.1%

4.5% 4.5% 4.7%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

NBRx Share TRx Share

BELBUCA NBRx Share Well Above TRx ShareIndicative of Future Growth Potential

Source: IQVIQ NPA DataNBRx = New-to-Brand Retail Prescriptions

TRx share increased by 24% YoY and increased compared to Q2 2021


BELBUCA is Continuously Building Prescriber Base

Source: Symphony Metys Data & Symphony Vantage Application

7,494

7,782

8,043 7,986

8,345

6,000

6,500

7,000

7,500

8,000

8,500

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

Adding 1,000+ New Prescribers for each

of the last 8 quarters

Unique prescribersincreased 11% YoY in

Q2 2021

BELBUCA Unique Prescribers


BELBUCA Enjoys Strong Formulary CoverageHistory of Consistent Year Over Year Growth Across All Payer Types

BELBUCA % Lives Preferred & Covered or Better BELBUCA TRx Count by Payer Type

Source: Fingertip Formulary & Symphony Vantage Application

60%

6%

39%

90%

33%

83%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Commercial Medicare All Payer Types

Preferred Covered or Better

53,97956,934

59,60056,530

60,566

37,778 39,35341,602

38,575 40,154

12,828 13,352 14,281 14,135 14,410

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

Commercial, Co-Pay and Cash Medicare Medicaid

+ 12.2% YoY Growth

+ 6.3% YoY Growth


Growing Policy Acceptance for BuprenorphineHHS Task Force

Health and Human Services (HHS) Task Force chartered by Congressional legislation and chaired by HHS includes more than 30 representatives from across federal government agencies, including: U.S. Food and Drug Administration • Centers for Disease Control and Prevention (CDC) • National Institutes of Health (NIH) • Office of National Drug Control Policy (ONDCP) Substance Abuse and Mental Health Services Administration (SAMHSA) • U.S. Department of Defense (DOD) • U.S. Department of Veterans Affairs (VA)

1 - Pain Management Best Practices Inter-agency Task Force Report Final Report May 20192, 3 - Pain Management Best Practices Inter-agency Task Force Report Final Report May 2019 – Page 29

HHS Task Force Report on management

of Chronic Pain, based on input from 30+ health / regulatory agencies,

recommended:

Recommendation 4A: Make buprenorphine treatment for chronic pain available for specific groups of patients and include buprenorphine in third-party payer and hospital formularies.2

Recommendation 4B: Encourage CMS and private payers to provide coverage and reimbursement for buprenorphine treatment, both for OUD and for chronic pain. Encourage primary use of buprenorphine rather than use only after failure of standard mu agonist opioids such as hydrocodone or fentanyl, if clinically indicated.3


OIC Affects ~50% of Patients Taking a Class II Opioid1

1. Market Research: Segmenting OIC Patient Universe.2. When People with Opioid-Induced Constipation Speak: A Patient Survey & Patient Preferences for Change in Symptoms Associated with Opioid-Induced Constipation, N = 513 OIC Patients.3. Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK; N = 1984. Movantik Prescribing Information.

• 94% of patients who took OTC laxatives* reported an inadequate response3

• Challenges with leading prescription products

⁃ Must be taken with food

⁃ Must stop use of laxatives

⁃ Associated with 20% instance of abdominal pain in starting dose4

*Defined as using at least one laxative ≥4 times over the previous two weeks

Up to 84%of patients with Opioid Induced Constipation (OIC) report negative impact on their quality of life2

Challenges with Leading Therapies


Symproic® Offers Differentiated Profile in Treating OICSymproic Blocks the Opioid Receptors in the Gut, Attacking OIC at its Source While Allowing the Opioid to Effectively Target the Patient’s Pain

The PAMORA with More Flexibility11

(Tablet is actual size)

• Has strong clinical evidence with robust long-term efficacy and tolerability

• Carries the highest recommendation from the American Gastroenterological Association

• Ideal complementary asset to BELBUCA and is promoted to overlapping HCP targets

• Allows for samples

• Patent Exclusivity through 2031

Once Daily Any time of day

With or without laxatives With or without food

11. Symproic Package Insert 05/2020.


Symproic® TRx Count & Share Since Acquisition

Symproic Quarterly TRx Count & TRx Share of PAMORA* Market16

,014

16,1

67 17,1

01

16,8

96

17,5

66

18,1

18

18,7

39

16,8

26 18,0

3110.4% 10.5% 11.1% 11.7%12.3% 12.5%

13.5%12.6% 12.7%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

7,000

9,000

11,000

13,000

15,000

17,000

19,000

Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

Symproic TRx Count Symproic TRx Market Share

Strong rebound over previous quarter with 7%QoQ growth in TRx count

Source: Symphony Metys Data, & Symphony Vantage Application *PAMORA Market: Symproic, Movantik and Relistor


Symproic NRx Count Reached a New High in Q2Symproic NRx Count Increased +7.6% from Q1 to Q2

9,860

10,163

10,628

9,961

10,715

7,000

7,500

8,000

8,500

9,000

9,500

10,000

10,500

11,000

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

13.4%13.6%

14.0%

13.3%

13.8%

10.0%

10.5%

11.0%

11.5%

12.0%

12.5%

13.0%

13.5%

14.0%

14.5%

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

Symproic NRx Count Symproic NRx Share

Source: Symphony Metys Data, & Symphony Vantage Application (Retail, Mail Order & LTC Data)NRx = New Prescriptions


4,729 4,727

4,950

4,7064,865

3,000

3,500

4,000

4,500

5,000

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

Unique Prescribers for Symproic Remain Encouraging

Symproic Unique Prescribers + 989 New Prescribers in Q2

Unique prescribersincreased 2.9% YoY in

Q2 2021

Source: Symphony Vantage Application


Symproic Favorable Formulary Coverage Continues

Symproic TRx Count in Prime Therapeutics & CVS

Source: Fingertip Formulary & Symphony Vantage Application

Symproic % Lives Preferred & Covered or Better

60%

6%

40%

89%

17%

80%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Commercial Medicare All Payer Types

Preferred Covered or Better


17.3

k

17.7

k

Symproic

331k

430k

BELBUCA

104.

6k

115.

2k

BELBUCA

BELBUCA & Symproic TRx Growth Relative to Market(Retail TRx Data)

Symproic 2020 vs 2019-5.1% PAMORA Market TRx Volume Decline

+13.9% Symproic TRx Volume Growth

11.9

M

10.7

M

LAO Market

592k

561k

PAMORA Market

BELBUCA 2020 vs 2019-10.0% LAO Market TRx Volume Decline

+29.8% BELBUCA TRx Volume Growth

Source: Symphony Vantage Application

BELBUCA Q2 2021 vs Q2 2020-10.4% LAO Market TRx Volume Decline

+10.1% BELBUCA TRx Volume Growth

61k 70

k

Symproic

Symproic Q2 2021 vs Q2 2020-2.1% PAMORA Market TRx Volume Decline

+2.0% Symproic TRx Volume Growth

2.7M

2.4M

LAO Market

141.

8k

138.

9k

PAMORA Market

2019 TRx Volume 2020 TRx Volume Q2 20 TRx Volume Q2 21 TRx Volume


ELYXYB Overview


Attractive Product Profile

• Headache pain freedom at 2 hours post-dose**

• Most Bothersome Symptom (MBS) freedom at 2 hours post-dose*

• Tmax of ~ 60 minutes

• Self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1

• Extensive qualitative and quantitative market research indicated strong intent to prescribe by research participants

• Highly attractive opportunity to diversify our product portfolio

• Establishes a growth platform in Neurology

• Leverages BDSI team’s commercial expertise and much of commercial and corporate infrastructure

• Patent protection until 2036

• Projected to be accretive in approximately 24 months from commercial launch

• Q1 2022 Launch planned

Deal RationaleDifferentiated Product in a Large & Growing Market

• The only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults

• Benefits from strong growth of the substantial and evolving migraine market

• Potential for pediatric label expansion, an additional indication for the treatment of acute pain, and includes the rights to commercialize in Canada.

ELYXYB Expands BDSI’s Presence in Neurology in Attractive Deal

* Results of 2 Pivotal studies comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving MBS freedom at 2 hours post dose being significantly greater than patients receiving placebo** Results of Pivotal study 2 comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving headache pain freedom at 2 hours post dose being significantly greater than patients receiving placebo1. Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)


Sales MilestonesTransaction Terms

ELYXYB Acquisition – Agreement Signed August 3, 2021*

• $6M upfront payment at closing

• $9M August 3, 2022

• Tiered Quarterly Earn-Out Payments in the high single-digit/low double-digit range based on net sales performance

• Contingent payments based on achieving certain regulatory milestones

• Sales milestone payments based on achieving certain net sales thresholds

* The closing of the transaction is subject to satisfactory completion of customary closing conditions, including the applicablewaiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).


$27.0$46.0

$97.5

$136.1

$8.1

$14.7

$62.01

$55.6

$111.4

$156.5

$0.0

$20.0

$40.0

$60.0

$80.0

$100.0

$120.0

$140.0

$160.0

2017 2018 2019 2020

$M

BELBUCA Symproic Other

Robust Annual Net Revenue Growth Trends

1. $20 M of deferred revenue included in 2017 upon termination of BDSI’s commercialization license with Endo Pharmaceuticals2. BUNAVAIL and royalty revenues

Total Net Revenue + 40%

in 2020 vs. 2019

BELBUCA Revenue + 40%

in 2020 vs. 2019

2


Sales Trajectory Driving Impressive Annual Gross Margin and Profitability

84.2%80.6%71.6%68.5%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

2020201920182017

% N

et S

ales

Gross Margin$40.5

$12.5

$(17.5)$(23.3) $(40.0)

$(25.0)

$(10.0)

$5.0

$20.0

$35.0

$50.0

2020201920182017

$M

EBITDA

26% of Net Sales

See appendix for GAAP to non-GAAP and EBITDA reconciliations

$25.7

$(15.3)$(21.7)

$5.3

$44.2

$13.2

$(33.9)

$(1.0)

$(45.0)

$(30.0)

$(15.0)

$-

$15.0

$30.0

$45.0

$60.0

2020201920182017

$M

Net Income/(Loss)

Non-GAAP

GAAP


Solid Quarterly Net Revenue Growth Trends YoY

1. 1. BUNAVAIL and product royalty revenues

Net Revenue Growth+13%

in Q2 2021 vs. Q2 2020 $32.3 $34.8 $35.6 $36.4 $36.5

$3.4 $3.5 $3.7 $4.4 $4.0$36.6

$39.4 $42.2 $41.0 $41.4

$-

$10.0

$20.0

$30.0

$40.0

$50.0

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

$M

BELBUCA Symproic Other 1


Attractive EBITDA Margins Driven by Healthy Gross Margins While Continuing to Invest to Support Brand Growth

89.7%85.8%80.3%86.4%85.1%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

Q2 2021Q1 2021Q4 2020Q3 2020Q2 2020

% N

et S

ales

Gross Margin

$13.1

$9.2

$14.3 $13.4

$5.1

$-

$5.0

$10.0

$15.0

Q2 2021Q1 2021Q4 2020Q3 2020Q2 2020

$M

EBITDA32% of

Net Sales

$1.2

$9.4 $10.2

$5.2 $9.1

$9.6

$12.7 $13.7

$8.5

$12.5

$-

$5.0

$10.0

$15.0

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

$M

Net Income

Non-GAAP

GAAP

See appendix for GAAP to non-GAAP and EBITDA reconciliations


As of June 30, 2021:

$119.9 million Cash and cash equivalents

$80 million Long-term debt

Operating Cash Flow of $9.2M in Q2 Supports Increasing Cash Balance

Share repurchase program authorized November 2020; Up to $25 million

$12.1 million used to repurchase 3.3 million shares through Q2 2021

Advantageously Positions BDSI for Continued Growth

$91.0 $100.2

$111.6 $116.4 $119.9

$-

$25.0

$50.0

$75.0

$100.0

$125.0

Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021

$M

Cash


2021 Expectations for Ongoing Business

Total Company Net Sales $170 - $180M

BELBUCA Net Sales $155 - $165M

Total Operating Expenses $115 - $120M

EBITDA $40 - $50M

Operating Cash Flow positive in 2021


Total Company Net Sales YoY Growth of 13%:

• BELBUCA +13%

• Symproic +18%

Solid Performance in Q2 2021 and Positioned Well for Future Growth

ELYXYB Acquisition Expands BDSI’s Presence in Neurology

• Attractive 32% EBITDA Margin

• $120M Cash Balance

• $9.2M Operating Cash Flow

• Strong balance sheet to support BDSI’s continued growth


Reconciliation of GAAP to Non-GAAP Metrics Q1 2020 – Q2 2021

QTD- Q1 QTD- Q2 QTD- Q3 QTD- Q4 QTD- Q1 QTD- Q23/31/2020 6/30/2020 9/30/2020 12/31/2020 3/31/2021 6/30/2021

GAAP Net Income 4,966$ 1,165$ 9,383$ 10,197$ 5,237$ 9,064$ Add back/(subtracts):

Income tax recovery/(provision) (278) 86 211 233 222 312 Net interest expense 1,294 1,685 2,012 2,022 1,979 1,999Depreciation and amortization 1,802 2,159 1,754 1,806 1,753 1,769

EBITDA 7,784$ 5,095$ 13,360$ 14,259$ 9,191$ 13,144$

GAAP Net Income 4,966$ 1,165$ 9,383$ 10,197$ 5,237$ 9,064$ Non-GAAP adjustments:

Stock-based compensation expense 1,520 1,364 1,473 1,750 1,490 1,697 Amortization of intangible assets 1,781 1,734 1,734 1,733 1,735 1,735 Non-recurring financial impact- CEO transition - 5,078 67 - - - Non- recurring financial impact- BUNAVAIL Discontinuation - 295 - - - -

Non-GAAP Net Income 8,267$ 9,636$ 12,657$ 13,679$ 8,462$ 12,496$

Reconciliation of GAAP Net Income to Non-GAAP Net Income

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES RECONCILIATION OF NON-GAAP METRICS

(U.S. DOLLARS, IN THOUSANDS) (Unaudited)

Reconciliation of GAAP Net Income/(Loss) to EBITDA (non-GAAP) 2020 2021

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