bdsi corporate overview - jefferies · 2017. 6. 15. · 1 © 2017 biodelivery sciences...

© 2017 BioDelivery Sciences International, Inc. All Rights Reserved.1 Do not copy, duplicate or distribute without express permission.

BDSI Corporate Overview

June 2017

© 2017 BioDelivery Sciences International, Inc. All Rights Reserved.2 Do not copy, duplicate or distribute without express permission.

Jefferies 2017 Healthcare Conference

June 6, 2017

Dr. Mark A. SirgoPresident and Chief Executive Officer

3 © 2017 BioDelivery Sciences International, Inc. All Rights Reserved.

,

Do not copy, duplicate or distribute without express permission.

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, those relating to the timing for completion, and results of, scheduled or additional clinical trials and the FDA’s or other regulatory review and/or approval and commercial launch and sales results (if any) of the Company’s formulations and products and regulatory filings related to the same, and receipt by the Company of milestone and royalty payments 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.


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BDSI – Fully Integrated Specialty Pharmaceutical Company Focused in Pain and Addiction MedicineLeveraging novel drug delivery technologies to develop and

commercialize new applications of proven therapeutics

Portfolio of Revenue Generating Products in Pain/Addiction:

BELBUCA® (buprenorphine) buccal film (CIII) – Chronic Pain

- Schedule III opioid for chronic pain; less abuse and addiction potential compared to Schedule II opioids

- Q1 2017 net sales of $4.6 million

- March net sales of $2.0 million; or $24 million net sales run rate

BUNAVAIL® (bup/naloxone) buccal film (CIII) – Opioid Dependence

- 64% growth in prescription volume in 2016

- 2017 exit net annual sales run-rate of >$10 million

ONSOLIS® (fentanyl buccal soluble film)(CII) – Cancer BTP

- Marketed in EU (BREAKYL), Taiwan (PAINKYL)

- Licensed to Collegium Pharmaceutical in the U.S. – 2018 Market Re-Entry

Continued progression of pipeline

- Sustained Release Buprenorphine Injection for opioid dependence; initial PK/PD data Q3


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BDSI Product Portfolio: Three Revenue Generating Products for Pain/Addiction

Formulation Development

Phase

I

Phase

II

Phase

III

NDA Approved/

Marketed

BELBUCA®

Buprenorphine HCl

buccal film

Chronic pain

BUNAVAIL®

buprenorphine and naloxone

buccal film

Opioid dependence

*Licensed to Meda for all territories outside North America except Taiwan (TTY BioPharm). North American rights licensed to Collegium Pharmaceutical.

Buprenorphine Depot Injection is an investigational drug and has not been approved for use by the FDA.

5

ONSOLIS®/BREAKYL™fentanyl buccal soluble film

Breakthrough cancer pain

Collegium Pharmaceutical/ Meda (ex-US)*

BDSI

BDSI

BDSIBuprenorphine Depot

InjectionOpioid dependence/Pain

6© 2017 BioDelivery Sciences International, Inc. All Rights Reserved. Do not copy, duplicate or distribute without express permission.

BDSI 1Q 2017 Accomplishments


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BDSI 1Q 2017 Key Accomplishments

Strong BDSI 1Q results, with net revenue of $29.5 million with BELBUCA® and BUNAVAIL® contributing $7.8 million (vs $2.1 million in Q1 2016)

March annualized BELBUCA revenue run rate of $24 million

Commercial business unit “profitability” reached in March

Significant progress made with ex-US licensing efforts

Debt financing completed providing cash runway to 2H 2018


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BDSI Product Revenue Growth

Change in method of accounting for BUNAVAIL sales from quarterly revenue reporting based on Symphony sales to actual sales in Q1 2017

Other royalties are for BEMA fentanyl products outside the U.S. - BREAKYL (EU) and PAINKYL (Taiwan)

$0.0

$1.0

$2.0

$3.0

$4.0

$5.0

$6.0

$7.0

$8.0

$9.0

$10.0

Q4 2016 Q1 2017

Net Revenue ($millions)

BUNAVAIL BELUCA Royalty BELBUCA Other Royalty Revenue

$ M

illio

ns


BELBUCA®

(buprenorphine) buccal film

BELBUCA is indicated for the management of pain severe enough to require daily, around-the-

clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Visit www.belbuca.com for important safety information

Treatment of Chronic Pain


,


Two Biggest Challenges for HCPs Prescribing Opioids for Chronic Pain

Addiction

&

Overdose


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Addressing Significant and Growing Challenges Facing HCPs Treating Pain with Opioids

Potential for misuse, abuse and addiction Over 2.5 million people in the U.S. with opioid dependence1

Risk of overdose Drug overdose is now the leading cause of accidental death in the U.S.2

Nearly 20,000 deaths are from prescription opioids 2

1 SAMHSA 2016 Opioid Addiction Facts & Figures

2 CDC


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Buprenorphine – A Differentiated Opioid

Unlike all CII opioids, Buprenorphine (CIII) is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor, providing:

Potent analgesia – 25-100x more

potent than morphine; binds tightly to

mu-opioid receptors and detaches

slowly

Less abuse and addiction potential

compared to Schedule II opioids such

as oxycodone, hydrocodone and

morphine

Exhibits a dose-ceiling effect on

respiratory depression (as it relates to

overdose)

American Journal of Addictions, Nov 2010

PCO2

DOSE

Ceiling effect

Dahan A, et al. Br J Anaesth. 2005


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.

BELBUCA Provides Effective Chronic Pain Relief

Opioid Experienced Patient Study (<160 mg MSE): Twice as many patients taking BELBUCA experienced at least a 50% reduction in pain score at week 12 versus patients taking placebo

Percentage Improvement in NRS Pain Score From Prior to Open-Label Titration to Study Endpoint


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The most common adverse reactions (>5%) reported by patients treated with BELBUCA in the clinical trials were nausea,

constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infections. See

www.Belbuca.com for more information including full prescribing information.

Well Tolerated with Rates of Side Effects Comparable to Placebo in Opioid Experienced Patients

Adverse Events in ≥ 5% of Patients in the Double-Blind Treatment Phase of Controlled Studies: Opioid-Experienced Patients

BELBUCA (buprenorphine) buccal film [package insert]. 2015.

Double-Blind Treatment Phase

MedDRA Preferred Term

BELBUCA (N=810) Placebo (n=256)

Nausea 7% 7%

Constipation 3% 1%

Vomiting 5% 2%

Headache 2% 3%

Dizziness 2% <1%

Somnolence 1% <1%

Drug Withdrawal Syndrome

4% 10%

http://www.belbuca.com/


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Butrans Chronic Pain Sales Exceeded $265 Million in 2016

MSE = Morphine Sulfate Equivalents

Butrans (buprenorphine transdermal patch) manufactured by Purdue Pharma.

Source: Symphony Health, Year end integrated sales.

$0

$50

$100

$150

$200

$250

$300

2011 2012 2013 2014 2015 2016

Millions

Butrans Annual Rx Sales


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BELBUCA® vs Butrans

MSE = Morphine Sulfate Equivalents

Butrans (buprenorphine transdermal patch) manufactured by Purdue Pharma.

Source: Symphony Health, Year end integrated sales.

BELBUCA® Provides:

Greater flexibility in dose titration:

7 BELBUCA dosage strengths (75, 150, 300, 450, 600, 750, 900 mcg) versus Butrans (5, 7.5, 10, 15, 20 mcg/hr)

Indicated for a broader range of patients

BELBUCA: opioid naïve through patients on 160mg MSE vs 80 mg MSE

Patient tolerability; no skin reactions

No residual drug substance at completion of dosing


BDSI Commercial Strategy


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BDSI Highly-Focused Commercial Strategy

BDSI Sales Force:

65 sales reps

5 regional sales managers

High potential BELBUCA targets (>6,700):

BELBUCA prescribers in prior 9 months

High prescribers of buprenorphine products (ie, Butrans, etc.)

LAO Rx deciles 8-10

BUNAVAIL prescribers (1,700)


BELBUCA Sales and Managed Care Progress


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BELBUCA Sales Growth

Returned prescription growth in March

Source: Symphony Health

*Projected based on weekly sales data through May 27

0

1000

2000

3000

4000

5000

6000

7000

BELBUCA TRx’s by Month

Increasing use of higher dose strengths

Endo BDSI

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

BELBUCA Unit Sales by Dose

75-300 MCG 450-900 MCG


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Broad Commercial Formulary Access

Covered on formularies representing >85% of the commercial Rx potential

Commercial Agreements

United Healthcare – Largest payer in U.S. (BELBUCA preferred over Butrans effective January 1, 2017)

Top 6 PBMs: Optum Rx, Caremark, Express Scripts, EnvisionRx, Prime Therapeutics, MedImpac

80% of commercial prescriptions approved

2017 opportunities with additional commercial payers and Medicare (represents 34% of LAO total prescriptions)


,


United Healthcare (UHC) Growth in BELBUCA Prescribing

0

100

200

300

400

500

600

700

800

900

Contract Implementation:

Preferred Status vs Butrans


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BELBUCA Commercial Summary

BELBUCA provides a meaningfully differentiated opioid for the treatment of chronic pain

High potential targets and current prescribers for BELBUCA to be Sales Force focus

Strong speakers programs; education around buprenorphine is critical

BELBUCA has favorable commercial formulary access; United Healthcare agreement provides a significant growth opportunity in 2017


BUNAVAIL®

(buprenorphine and naloxone) buccal film

Treatment of Opioid Dependence

BUNAVAIL is indicated for the maintenance treatment of opioid dependence .

BUNAVAIL should be used as part of a complete treatment plan to include counseling

and psychosocial support.

Visit www.bunavail.com for important safety information


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Opioid Dependence Remains Under Diagnosed & Undertreated

Treated with Opioids for

Pain1

N=>48MM

Develop Dependence2

N=5MM

Diagnosed Dependent3

N=2.5MM

Treated with buprenorphine4

N=~550K

Widespread opioid use – lack of alternatives

Most users unaware of their own dependence, do not seek treatment or are not diagnosed.

Poor treatment compliance, complex patient population and lack of prescribing physicians

1) National Institute on Drug Abuse (NIDA) 3) 2012 National Survey on Drug Use and Health, US Dept of Health and Human Services2) NSDUH , NIDA website 4) Symphony Health Solutions, January 2014


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Market Dynamics:

Suboxone film generated

nearly $1.6 billion in

sales in 2015

Market showing

continued growth from

2015 to 2016 (+11%)

Market Sales Exceeded $2.2 Billion in 2016

Symphony Health; integrated sales of buprenorphine products for opioid dependence through 2016. US Sales only.

.

$0

$500

$1,000

$1,500

$2,000

$2,500

2011 2012 2013 2014 2015 2016

Millio

ns

BUPRENORPHINE HCL BUPRENORPHINE-NALOXONE SUBOXONE TAB

ZUBSOLV BUNAVAIL SUBOXONE


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Recent Passage of Legislation to Improve Access to Buprenorphine Treatment

1 Department of Health and Human Services, 42 CRF Part 8.

2 Substance Abuse and Mental Health Services Administration, Press release September 27, 2016

2 Estimate based on average of 6 Rx’s per patient

HHS Increase to Patient Limit Implemented

Increased patient cap from 100 to 275 patients (August 2016)

Anticipated impact in the first 12 months:

Up to 1800 practitioners expected to request approval to increase to the higher limit 1 (1665 applications approved through late September)2

Up to 90,000 additional patients may receive buprenorphine1

Potential for > ½ million new prescriptions3

Comprehensive Addiction and Recovery Act (CARA)

Expands office-based treatment by allowing NP’s and PA’s to prescribe buprenorphine


BUNAVAIL 2017 Sales Focus


,


BUNAVAIL Sales Force Focus

Support current BUNAVAIL high prescribers and their patients

~1,700 HCPs

Covers ~95% of previous TRx’s


,


BUNAVAIL Sales Performance

0

5000

10000

15000

20000

25000

30000

35000

Total Prescription Sales by Quarter

* Symphony Health, April 2017. Integrated retail and non-retail topline sales.

2016 Sales Summary:

— Total Prescription Sales:

• 114,496 total Rx’s

(+64% over 2015)

— Total Dollar Sales:

• $20.1 million* (+67% over 2015)


Sustained Release Buprenorphine Injection


,


SR Buprenorphine Injection

Uses proprietary FormEZE® microparticle technology licensed from Evonik Corporation to produce a formulation of buprenorphine potentially capable of providing 30 days of continuous opioid therapy

Data from first study (initial cohort) anticipated in Q3:

Single, ascending dose study – opioid dependent subjects

Assessment of PK, PD, efficacy benchmarks and tolerability

Confirm 30 day profile


,


Buprenorphine Depot Injection Formulation Meets Desired Profile – 30 Day, Low Burst Effect

Non-GLP and GLP Plasma Buprenorphine Concentration vs. Time Profile

Following Single Doses Buprenorphine Depot in Gottingen Minipigs

hours


Summary


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BDSI Value Drivers in 2017

BELBUCA March revenue run rate of $24 million and growing

Commercial business unit profitability

BELBUCA ex-U.S. partnership(s) and potential U.S. co-promote

Anticipated BELBUCA approval in Canada in 2Q 2017

Continued managed care contract enhancements and wins for BELBUCA and BUNAVAIL to drive future growth

Sustained Release Buprenorphine Injection single, ascending dose study results by 4Q


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Balance Sheet Highlights

Cash position

$35.2 million – as of March 31, 2017

Debt financing announced February 23, 2017

- $45 million at closing

- Ability to access additional funding - aggregate of $30 million in two tranches

Cash runway into 2H 2018

Average Volume (3 months)1

>630,000 shares

BDSI: 54,796,612 million shares outstanding2

1 May 30, 2017

2 March 2017

Follow BDSI on Facebook and Twitter

bdsi corporate overview - jefferies · 2017. 6. 15. · 1 © 2017 biodelivery sciences...

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