BDSI Corporate Overview
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1 BDSI Corporate Overview June BioDelivery Sciences International Inc. All Rights Reserved.
2 Jefferies 2017 Healthcare Conference Dr. Mark A. Sirgo President and Chief Executive Officer June BioDelivery Sciences International Inc. All Rights Reserved.
3 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 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 BioDelivery Sciences International Inc. All Rights Reserved.
4 BDSI Fully Integrated Specialty Pharmaceutical Company Focused in Pain and Addiction Medicine Leveraging 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 - Q 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 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 Market Re-Entry Continued progression of pipeline - Sustained Release Buprenorphine Injection for opioid dependence; initial PK/PD data Q BioDelivery Sciences International Inc. All Rights Reserved.
5 BDSI Product Portfolio: Three Revenue Generating Products for Pain/Addiction 5 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 BDSI BDSI ONSOLIS /BREAKYL fentanyl buccal soluble film Breakthrough cancer pain Buprenorphine Depot Injection Opioid dependence/pain Collegium Pharmaceutical/ Meda (ex-us) * BDSI *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 BioDelivery Sciences International Inc. All Rights Reserved.
6 BDSI 1Q 2017 Accomplishments BioDelivery Sciences International Inc. All Rights Reserved.
7 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 BioDelivery Sciences International Inc. All Rights Reserved.
8 $ Millions BDSI Product Revenue Growth $10.0 Net Revenue ($millions) $9.0 $8.0 $7.0 $6.0 $5.0 $4.0 $3.0 $2.0 $1.0 $0.0 Q Q BUNAVAIL BELUCA Royalty BELBUCA Other Royalty Revenue Change in method of accounting for BUNAVAIL sales from quarterly revenue reporting based on Symphony sales to actual sales in Q Other royalties are for BEMA fentanyl products outside the U.S. - BREAKYL (EU) and PAINKYL (Taiwan) BioDelivery Sciences International Inc. All Rights Reserved.
9 Treatment of Chronic Pain BELBUCA (buprenorphine) buccal film BELBUCA is indicated for the management of pain severe enough to require daily around-theclock long-term opioid treatment and for which alternative treatment options are inadequate. Visit for important safety information BioDelivery Sciences International Inc. All Rights Reserved.
10 Two Biggest Challenges for HCPs Prescribing Opioids for Chronic Pain Addiction & Overdose BioDelivery Sciences International Inc. All Rights Reserved.
11 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 dependence 1 Risk of overdose Drug overdose is now the leading cause of accidental death in the U.S. 2 Nearly deaths are from prescription opioids 2 1 SAMHSA 2016 Opioid Addiction Facts & Figures 2 CDC BioDelivery Sciences International Inc. All Rights Reserved.
12 Buprenorphine A Differentiated Opioid Unlike all CII opioids Buprenorphine (CIII) is a partial agonist at the muopioid receptor and an antagonist at the kappa-opioid receptor providing: Potent analgesia x 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) PCO 2 Ceiling effect Dahan A et al. Br J Anaesth American Journal of Addictions Nov 2010 DOSE BioDelivery Sciences International Inc. All Rights Reserved.
13 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 BioDelivery Sciences International Inc. All Rights Reserved.
14 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 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% BELBUCA (buprenorphine) buccal film [package insert] 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 for more information including full prescribing information BioDelivery Sciences International Inc. All Rights Reserved.
15 Millions Butrans Chronic Pain Sales Exceeded $265 Million in 2016 $300 Butrans Annual Rx Sales $250 $200 $150 $100 $50 $ MSE = Morphine Sulfate Equivalents Butrans (buprenorphine transdermal patch) manufactured by Purdue Pharma. Source: Symphony Health Year end integrated sales BioDelivery Sciences International Inc. All Rights Reserved.
16 BELBUCA vs Butrans BELBUCA Provides: Greater flexibility in dose titration: 7 BELBUCA dosage strengths ( mcg) versus Butrans ( 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 MSE = Morphine Sulfate Equivalents Butrans (buprenorphine transdermal patch) manufactured by Purdue Pharma. Source: Symphony Health Year end integrated sales BioDelivery Sciences International Inc. All Rights Reserved.
17 BDSI Commercial Strategy BioDelivery Sciences International Inc. All Rights Reserved.
18 BDSI Highly-Focused Commercial Strategy BDSI Sales Force: 65 sales reps 5 regional sales managers High potential BELBUCA targets (>6700): BELBUCA prescribers in prior 9 months High prescribers of buprenorphine products (ie Butrans etc.) LAO Rx deciles 8-10 BUNAVAIL prescribers (1700) BioDelivery Sciences International Inc. All Rights Reserved.
19 BELBUCA Sales and Managed Care Progress BioDelivery Sciences International Inc. All Rights Reserved.
20 BELBUCA Sales Growth Returned prescription growth in March Increasing use of higher dose strengths 7000 BELBUCA TRx s by Month Endo BDSI 100% BELBUCA Unit Sales by Dose % 80% 70% % 50% % % % 10% 0 0% MCG MCG Source: Symphony Health *Projected based on weekly sales data through May BioDelivery Sciences International Inc. All Rights Reserved.
21 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 ) 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) BioDelivery Sciences International Inc. All Rights Reserved.
22 United Healthcare (UHC) Growth in BELBUCA Prescribing 900 Contract Implementation: Preferred Status vs Butrans BioDelivery Sciences International Inc. All Rights Reserved.
23 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 BioDelivery Sciences International Inc. All Rights Reserved.
24 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 for important safety information BioDelivery Sciences International Inc. All Rights Reserved.
25 Opioid Dependence Remains Under Diagnosed & Undertreated Treated with Opioids for Pain 1 N=>48MM Develop Dependence 2 N=5MM Diagnosed Dependent 3 N=2.5MM 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 Treated with buprenorphine4 N=~550K 1) National Institute on Drug Abuse (NIDA) 3) 2012 National Survey on Drug Use and Health US Dept of Health and Human Services 2) NSDUH NIDA website 4) Symphony Health Solutions January BioDelivery Sciences International Inc. All Rights Reserved.
26 Millions Market Sales Exceeded $2.2 Billion in 2016 $2500 $2000 $1500 Market Dynamics: Suboxone film generated nearly $1.6 billion in sales in 2015 $1000 Market showing continued growth from 2015 to 2016 (+11%) $500 $ BUPRENORPHINE HCL BUPRENORPHINE-NALOXONE SUBOXONE TAB ZUBSOLV BUNAVAIL SUBOXONE Symphony Health; integrated sales of buprenorphine products for opioid dependence through US Sales only BioDelivery Sciences International Inc. All Rights Reserved.
27 Recent Passage of Legislation to Improve Access to Buprenorphine Treatment 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 additional patients may receive buprenorphine 1 Potential for > ½ million new prescriptions 3 Comprehensive Addiction and Recovery Act (CARA) Expands office-based treatment by allowing NP s and PA s to prescribe buprenorphine 1 Department of Health and Human Services 42 CRF Part 8. 2 Substance Abuse and Mental Health Services Administration Press release September Estimate based on average of 6 Rx s per patient BioDelivery Sciences International Inc. All Rights Reserved.
28 BUNAVAIL 2017 Sales Focus BioDelivery Sciences International Inc. All Rights Reserved.
29 BUNAVAIL Sales Force Focus Support current BUNAVAIL high prescribers and their patients ~1700 HCPs Covers ~95% of previous TRx s BioDelivery Sciences International Inc. All Rights Reserved.
30 BUNAVAIL Sales Performance Total Prescription Sales by Quarter 2016 Sales Summary: Total Prescription Sales: total Rx s (+64% over 2015) Total Dollar Sales: $20.1 million* (+67% over 2015) * Symphony Health April Integrated retail and non-retail topline sales BioDelivery Sciences International Inc. All Rights Reserved.
31 Sustained Release Buprenorphine Injection BioDelivery Sciences International Inc. All Rights Reserved.
32 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 BioDelivery Sciences International Inc. All Rights Reserved.
33 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 BioDelivery Sciences International Inc. All Rights Reserved.
34 Summary BioDelivery Sciences International Inc. All Rights Reserved.
35 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 BioDelivery Sciences International Inc. All Rights Reserved.
36 Balance Sheet Highlights Cash position $35.2 million as of March Debt financing announced February $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 > shares BDSI: million shares outstanding 2 1 May March 2017 Follow BDSI on Facebook and Twitter BioDelivery Sciences International Inc. All Rights Reserved.
Suboxone, Zubsolv, Bunavail (buprenorphine with naloxone sublingual tablets and film), Buprenorphine sublingual tablets
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.32 Subject: Suboxone Drug Class Page: 1 of 7 Last Review Date: June 24, 2016 Suboxone Drug Class Description
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