Tuesday June 7, 2016 - Braeburn Pharmaceuticals

Presentation to the Jefferies Healthcare Conference
Tuesday June 7, 2016
Forward-Looking Statements
Some of the statements in this presentation constitute forward-looking statements. Forward-looking statements relate to expectations,
beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not
historical facts. The forward looking statements contained in this presentation involve risks and uncertainties as well as statements as to:
 availability of investment opportunities;
 changes in our business strategy;
 our ability to consummate an appropriate investment opportunity within given time constraints;
 availability of qualified personnel;
 changes in our industry, interest rates, the debt securities markets or the general economy;
 changes in governmental regulations, tax rates and similar matters;
 changes in generally accepted accounting principles by standard-setting bodies; and
 the degree and nature of our competition.
The forward-looking statements are based on our beliefs, assumptions and expectations of our future performance, taking into account
all information currently available to us. These beliefs, assumptions and expectations can change as a result of many possible events or
factors, not all of which are known to us or are within our control. If a change occurs, our business, financial condition, liquidity and
results of operations may vary materially from those expressed in our forward-looking statements.
6/7/2016
2
Braeburn Vision
A pill-free pharma company delivering precision medicine in neuroscience
Braeburn’s novel, long-acting implants and injectables improve public health and social
cost outcomes associated with drug diversion, misuse and non-compliance
•
Guaranteeing length of therapy improves both outcomes
Eight programs in three related multi-billion dollar markets
•
•
3 Opioid Addiction (buprenorphine)
•
3 Pain (buprenorphine)
•
2 Schizophrenia (risperidone, ATI-9242)
7 out of 8 programs are 505(b)2 programs, with potentially lower cost and regulatory
risk
•
First Approval: Probuphine on May 26, 2016; at least one product launch each year
thru 2020
All products are focused around neuropsychiatric indications where team expertise is
strong and unmet clinical need is high
6/7/2016
3
Management Team
Behshad Sheldon
President & CEO
Marshall Woodworth
CFO
Frank Young, MD, PhD
EVP, Medical and Regulatory
Sonnie Kim, PharmD
VP, Clinical and Medical Affairs
Craig Brown
VP, Commercial, Project
Management & Manufacturing
Enrique Arvelo
VP, Business Analytics
Jonathan Young, JD, PhD
General Counsel & VP,
Policy/Advocacy
6/7/2016
 Otsuka Pharmaceuticals, SVP Global Commercial Lead and Board Member of R&D company
• Launched and led development and commercialization efforts for Abilify® for 12 years
• Otsuka/Lundbeck landmark $10B CNS deal
 Bristol-Myers Squibb / Smithkline Beecham
• Plavix®, Glucophage®, Abilify® , Bactroban
 Aerocrine AB, CFO
 Furiex Pharmaceuticals, CFO
 Xerium Technologies / Milliken and Company / Monsanto / Dow Chemical / Eli Lilly
 U.S. Food & Drug Administration, Commissioner
 Essex Woodlands, Partner
 University of Rochester, Dean of Medical School; VP, Health Affairs; Chairman Dpt. of Microbiology
• Authored over 200 scientific articles in the fields of biotechnology and microbiology
 Otsuka Pharmaceuticals. Director, Medical Affairs/Hospital Medicine
 University of Maryland Medical System. Director, Pain Clinic
 Columbia Medcom Group, Inc. VP and board member
 Otsuka Pharmaceuticals, Sr. Director, Marketing – Abilify, Brexpiprazole
 Bristol-Myers Squibb, Associate Director – Stadol NS (pain)
 Westwood Squibb – Dermatology
 Otsuka Pharmaceuticals, Sr. Director, Global Commercialization and Portfolio Management
 Bristol-Myers Squibb, Associate Director
 Procter & Gamble, Group Manager
 FoxKiser, Partner and General Counsel
 National Council on Disability, Chairman
 The Clinton White House, Executive Office of the President, Assoc. Dir. Disability Policy
4
Markets Summary
Today’s
Patients
Opioid Use Disorder
Chronic Pain
Dependent
N~5M
~45M Full
Agonist
Schizophrenia
1%
Population
Diagnosed
N~2.4M
Treated
N~1,100K
Buprenorphine
N~825K
~1M Methadone
~825K
Buprenorphine
~15% on
Long Acting Formulations
Growth
Drivers
• Opioid Use Disorder (OUD) is a rising national epidemic
• Significant off-label use of buprenorphine for pain
– Less than 1 in 5 opioid dependent patients treated
• Heightened awareness of buprenorphine as an accepted
treatment modality for pain will drive physicians and
• Buprenorphine treatment is becoming the standard of care
patients towards on-label use
• Patient share is increasing relative to methadone
• Long term formulations are increasingly preferred in other
therapeutic areas – pain to follow this trend
• Long acting formulations are poised to become
the gold standard treatment for Schizophrenia
• 4 companies are currently promoting long
acting formulations
• Patient demographics suit long acting solutions
• CDC directive that full agonists are overprescribed and
alternatives are needed
Future
Patients
(10yrs+)
6/7/2016
• >1.5 Million patients on buprenorphine
• Approx. 1.5 Million patients on buprenorphine
• Patient penetration of long acting formulations over 20%
• Patient penetration of long acting formulations over 20%
• Approx. 2.4 Million patients on
schizophrenia therapies
• Patient penetration long acting formulations
over 25%
5
Braeburn Product Launch Trajectory
2016E
2017E
2018E
2019/2020E
Addiction Franchise
Probuphine
6 Months Buprenorphine Implant
Approval May 26, 2016
Launch: June 2016
Camurus Weekly / Monthly
Buprenorphine Injectable
Launch: Late 2017 / Early 2018
Pain Franchise
Camurus Weekly / Monthly
Buprenorphine Injectable
Launch: Early 2018
Probuphine
6 Months Buprenorphine Implant
Launch: Late 2018
Anti-Psychotic Franchise
Risperidone
Risperdal Implant
Launch: Mid 2018
2nd
Launch
1st
Launch
Total
Cumulative
Assets:
6/7/2016
3rd
Launch
7
ATI – 9242
Novel, Atypical Anti-Psychotic
Launch: Late 2019/2020
4th
Launch
8
3
1
6
Braeburn Receives FDA Approval for Probuphine May 26, 2016
Braeburn Pharmaceuticals Announces Commercialization Plans
for Probuphine® (buprenorphine) Implant, Six Month Treatment for Opioid Dependence
Braeburn Pharmaceuticals will make Probuphine available to healthcare providers and patients on June 13th, less
than three weeks following Food and Drug Administration (FDA) approval on May 26, 2016.
• Braeburn’s top launch priorities
1. Train and certify healthcare providers across the country in accordance with REMS program
2. Establish insurance coverage as quickly as possible
• 14 payer meeting in the first 12 days post-approval
• 5182 healthcare providers have requested information on Probuphine training
• 262 Probuphine training sessions across 55 cities over the next six weeks, will train >2000 HCPs
• 499 clinicians certified in first 10 calendar days post-approval
• Braeburn will continue to hold training sessions frequently throughout the year and will have the capacity to
train more than 4,000 healthcare providers by the end of 2016.
6/7/2016
8
Probuphine Post-Approval HCP Training Plan
Cumulative Scheduled and Projected Post-Approval HCP Certifications
Scheduled
Projected
4,000
3,670
3,341
3,500
3,011
3,000
2,682
2,500
2,000
1,598
1,838
2,352
1,271
1,500
943
1,000
500
2,250
2,012
499
83
4
0
Week 1
Week 2
Week 3
Week 4
Week 6
Week 7
Week 8
Week 9
Week 10
August September October November December
Scheduled Locations
Week 1
Location
6/7/2016
Week 2
 Miami, FL
 Charlotte, NC
 Philadelphia, PA  Cincinnati, OH
 Detroit, MI
 New York City
 Phoenix, AZ
 Pittsburgh, PA
 Salt Lake City
Week 3







Albuquerque, NM 
Baltimore, MD

Boston, MA

Cleveland, OH

Louisville, KY

Miami, FL

Rochester, NY

Week 4
Asheville, NC
Charleston, WV
Chicago, IL
Indianapolis, IN
Portland, ME
San Francisco
Washington, DC
Week 6







Columbus, OH
Los Angeles, CA
Manchester, NH
Minneapolis, MN
Philadelphia, PA
Portland, OR
St. Louis, MO
Week 7







Albany, NY
Atlanta, GA
Charleston, SC
Grand Rapids, MI
New Orleans, LA
Orlando, FL
San Antonio, TX
Week 8






Birmingham, AL
Dallas, TX
Denver, CO
Memphis, TN
Richmond, VA
Tampa, FL
Week 9








Anchorage, AK
Honolulu, HI
Houston, TX
Jacksonville, FL
Nashville, TN
Oklahoma City
San Diego, CA
Seattle, WA
Week 10
 Burlington, VT
 Las Vegas, NV
 San Juan, PR
9
Buprenorphine TRx by State
6/7/2016
10
Braeburn Training Sites by Location
6/7/2016
11
Probuphine® Distribution Model and Reimbursement Support
• Top 100 Commercial, FFS Medicaid and Managed Medicaid represent approximately 86% of the insured
Buprenorphine oral sales*
• Phased approach to Reimbursement
•
•
•
Phase I
• 38 Commercially Insured Targeted Accounts representing $682 M in oral buprenorphine sales
• 18 Eastern/Mid-Atlantic US
• 10 Midwest/South US
• 10 Western US
Phase II
• 56 Managed Medicaid & FFS Medicaid representing $469 M in oral buprenorphine sales
• 23 Eastern/Mid-Atlantic US
• 18 Midwest/South
• 15 Western US
Phase III
• 9 Medicare Administrative Contractors
* 2015 IMS PlanTrak Sales
Payer Coverage and Reimbursement
Payers who have communicated Probuphine coverage since May 31st
Plan Name
Rank
Oral Buprenorphine Sales
• CareSource
#02
$45.4 M
• Highmark BCBS
#20
$15.6 M
• BCBS of MA
#38
$08.4 M
Market Access & Government Affairs
Targeting “Open” payer benefit design first
Rank
2
7
8
9
10
19
21
25
31
38
39
41
42
43
45
51
53
57
65
75
78
79
Account Name
Plan Type
Plan Design
Geography
Oral Buprenorphine Dollars
WELLPOINT/ANTHEM BCBS
Commercial
Open
National
$
40,300,000
AETNA INC.
Commercial
Open
National
$
23,900,000
BCBS HEALTHCARE SERVICE CORP
Commercial
Open
Midwest/South $
23,500,000
CIGNA
Commercial
Open
National
$
23,500,000
FEHB
Commercial
Open
National
$
23,000,000
BCBS of MI
Commercial
Open
Michigan
$
16,700,000
HIGHMARK BCBS
Commercial
Open
PA/WV/OH
$
15,600,000
BCBS ALABAMA
Commercial
Open
AL
$
10,800,000
BCBS FL
Commercial
Open
FL
$
9,900,000
BCBS NC
Commercial
Open
NC
$
8,700,000
BCBS of MA
Commercial
Open
MA
$
8,400,000
BC INDEPENDENCE
Commercial
Open
PA/DE
$
7,800,000
BCBS LA
Commercial
Open
LA
$
7,700,000
BCBS TN
Commercial
Open
TN
$
7,700,000
HORIZON BCBS
Commercial
Open
NJ
$
7,300,000
HARVARD PILGRIM
Commercial
Open
MA
$
5,700,000
BC PREMERA
Commercial
Open
WA/OR
$
5,200,000
BCBS SC
Commercial
Open
SC
$
4,600,000
BCBS HEALTH NOW
Commercial
Open
NY
$
3,800,000
BCBS RI
Commercial
Open
RI
$
3,000,000
BCBS ARKANSAS
Commercial
Open
AR
$
2,600,000
BCBS REGENCE
Commercial
Open
WA/ID/UT
$
2,600,000
*Commercially insured plans ranking by oral Buprenorphine sales – IMS Plantrak 2015
Coding and Reimbursement Progress
• Completed HCPCS Application submitted to CMS on June 1, 2016 for establishing specific Probuphine
drug code
• CMS Rebate Agreement will be submitted on or before June 13th coverage to begin by July 15th
• 3 meetings with CMS have taken place to establish interim Q Codes and G Codes to address the National
Program Operating Needs for physicians and payers
• AMA CPT Coding Change Proposal to be submitted by ASAM by June 30th to address reimbursement
levels pursuant to a 4 rod drug delivery system
• Federal Supply Schedule Contract to be submitted by June 20th
Probuphine FDA Approval and Related Media Coverage
May 26, 2016 – June 3, 2016
National Feature Story Highlights
6/7/2016
17
Regional Media Highlights
6/7/2016
18
Trade Media Highlights
6/7/2016
19
Earned Media Coverage Summary To Date
85+ original stories
Mostly national features
More than 80 mentions
on local broadcast stations across the US
1,180 syndicated stories
• Wire stories drive coverage
Over
1 billion
total impressions
• Multiple stories in top DMAs
• Online, broadcast and print
6/7/2016
20
Aligning with Influencers
“Solutions for a New Way Forward”
•
•
•
•
Chris Christie, Governor, New Jersey
Leonard Campanello, Chief of Police, Gloucester, Mass
Behshad Sheldon, President and CEO, Braeburn
Dr. Andrea Barthwell, Former Deputy Director, ONDCP
6/7/2016
Experts including American Society of Addiction
Medicine President-Elect Dr. Kelly Clark and National
Institute on Drug Abuse, (NIDA), discuss medication
assisted treatment of opioid use disorder.
21
Social Media Highlights
859 posts
5,535,753 impressions
6/7/2016
22
Addiction Market and Franchise
Opioid Addiction Market
CDC Has Declared an Opioid Epidemic in the US
• 2.4 million patients in the US with Opioid Use Disorder (heroin and illicit Rx-opioid use)
• ~$2B buprenorphine oral daily market, treating ~30% of diagnosed opioid addicted
patients1
– Suboxone® Peak Sales: $1.5B in 2012, $1.5B in 2015
– New entrants Orexo/BDSI limited to daily sublingual/buccal patch
– Relief, but with inconvenience, potential for diversion, abuse, and accidental
pediatric exposure
• Methadone Clinics
– ~330,000 patients
– “Liquid Handcuffs”
– Fogginess
• Vivitrol
– 2015 sales $174M, 60% growth in sales from 2014
– Only non opioid medical assistance treatment
– High drop out rates
• Rehab/12-step programs – Promoting abstinence
– $30-40k per month
– High relapse rates and mortality post-treatment
1
2
IMS National Sales Perspective. Dollars MAT March 2015
IMS National Sales Perspective. Dollars Calendar 2014
US Buprenorphine Oral Market Continues to Grow
12
TRx MM
+16%
8
+58%
+13%
+12%
+8%
+19%
4
•
11.6 million TRx in 2015
•
TRx robust growth continued
•
Market grew 1.9x in the past 5 years
•
Very concentrated market, with >85% of
Rx’s from 5,250 prescribers
0
2009
2010
2011
2012
2013
2014
2015
$2,000
US$ MM
$1,500
$1,000
$500
•
$2 Billion in sales in 2014
•
The market continues to grow despite 4
generic competitors
$
2009
2010
2011
2012
Indivior (formerly Reckitt Benckiser)
6/7/2016
2013
2014
2015
All Others
25
Source: TRx IMS NPA; Sales IMS NSP
Treatment of Opioid Dependence
Braeburn intends to shift the treatment paradigm by replacing daily sublingual
products with a suite of complementary long-acting medications for patients at all
stages of recovery:
Early Stage Treatment
• Patients are required to make at least weekly visits
• Trust required, as commonly seven days worth of drug given at one time
• Some patients need the structure of more regular visits longer-term
• Braeburn Solution: CAM2038 Weekly injection
Maintenance Treatment
• Patients “graduate” to less frequent, monthly visits as they make progress in
behavior modification
• Some patients have even less frequent access/need to see their clinician
• Braeburn Solutions : CAM2038 Monthly injection and Probuphine® sixmonth implant
6/7/2016
26
Benefits of Braeburn’s Addiction Franchise
Patient Benefit
•
Freedom from burdens of daily medication
•
Flexible and personalized dosing
•
Increased compliance- no ability to take “drug holiday” and get high
•
No daily reminders of disease or reinforcement of drug-taking behavior
by taking daily buprenorphine
Clinician Benefit
•
Assurance that dose given is dose taken
•
Peace of mind regarding patients diverting medication
Public Health/Payer Benefit
•
•
Helps improve issues with daily buprenorphine
•
Diversion, abuse
•
Accidental pediatric exposure
•
“Pill mills”
7-12x ROI for treatment of opioid addiction
6/7/2016
27
Probuphine Six-Month Implant
Licensed from Titan Pharmaceuticals in December 2012
•
Implant smaller than matchstick (~1 inch or <30mm)
•
Administered as four subcutaneous implants in upper arm
Enrollment of 177 patients in 4 months far outpaced typical
enrollment schedule of 6-9 months
Offers sustained release of buprenorphine for six months
Phase III studies
•
•
•
Two Phase III trials demonstrated statistically significant
separation from placebo in unstable patients, FDA CRL
Third Phase III trial conducted following agreement with FDA
about studying Probuphine® in patients stabilized on lower
doses of sublingual buprenorphine: positive results released
June 2015
Would be first marketed long-acting buprenorphine product
Approval: May 26, 2016
Launch: June, 2016
1
6/7/2016
IMS National Sales Perspective. Dollars MAT March 2015
2 IMS National Sales Perspective. Dollars Calendar 2014
Braeburn reached agreement with FDA on study protocol (2014)
Braeburn has successfully executed on an aggressive trial
schedule and NDA submission
•
May 15th 2014: Final FDA advice on proposed protocol
•
July 17th 2014: First patient enrolled
•
June 2015: Positive topline data released
•
August 2015: NDA Submission
•
February 2016: FDA 3 Month Delay
•
May 26, 2016: FDA Approval
28
CAM-2038 Weekly and Monthly Injections
Monthly and Weekly injection FluidCrystal® nanotechnology
formulation. North American rights licensed from Camurus AB in
November 2014
•
Option for Asian markets
Formulation attributes:
•
Fast onset and long-acting duration
•
Ready-to use subcutaneous administration
•
Small volume, low-viscosity, subcutaneous injection
•
Pre-filled syringe with very small needle
•
Good local tolerability
•
No refrigeration needed
•
Personalized therapy – different durations and multiple dose strengths
•
Began enrollment in pivotal program in 4Q 2015
•
The FDA has granted Fast Track status to these two formulations.
Expected approval: Late 2017 / Early 2018
(both weekly and monthly injections)
6/7/2016
29
High Physician Interest in Long-Acting Products
Target Product Profile (“TPP”) shown to 150 buprenorphine prescribing physicians
Intent to Inject Once-monthly
6/7/2016
Intent to Implant Probuphine
Likelihood to Inject
% of Doctors
Patient Share
Likelihood to Implant
% of Doctors
Patient Share
Definitely Would
24%
57%
Definitely Would
11%
33%
Probably Would
27%
41%
Probably Would
24%
23%
Possibly Would
26%
28%
Possibly Would
36%
19%
Total
77%
32.1%
Total
71%
15.7%
30
Pain
Significant Upside for Long-Acting Buprenorphine in Pain
Braeburn to pursue pain solutions using Probuphine and both the weekly and monthly CAM-2038 injectable
formulations
Large market opportunity: over 100 million people suffer from chronic pain (48+ million treated with opioids)
Buprenorphine has been shown to be effective in pain
•
Buprenex, first ever buprenorphine approved product in 1981, is an injection for acute pain
•
Butrans® (Purdue): 7-day buprenorphine patch approved for pain in 2010
•
BEMA buprenorphine (BioDelivery/Endo): FDA approved 2015
•
~50% of buprenorphine oral is being used off label to treat pain
Long-acting formulations of buprenorphine may benefit patients by:
•
Limiting peaks and troughs of daily medications
•
Breaking the cycle of pain and minimizing anticipatory worsening of pain
•
Minimizes potential for pill-mills, diversion and abuse
•
Simplifying drug regimen vs daily medication
6/7/2016
32
Buprenorphine – Mechanism of Action (Pain)
Buprenorphine may have additional mechanistic advantages vs full mu receptor agonists
(oxycodone, hydrocodone, morphine, etc.)
Mu
6/7/2016
Kappa
(analgesia, euphoria,
respiratory depression)
(dysphoria,
hyperalgesia,
antinorciceptive)
Delta
ORL1
(minor analgesia)
(spinal analgesia)
Buprenorphine
Partial agonist
Strong affinity
Antagonist
Strong affinity
Antagonist
Moderate affinity
Agonist
Morphine
Full agonist
Moderate affinity
Weak agonist
Very Low affinity
Weak agonist
Very low affinity
N/A
Naltrexone
Antagonist
Strong affinity
Antagonist
Moderate affinity
Antagonist
Very Low affinity
Antagonist
33
Buprenorphine’s Potential
Advantages vs. Full Agonists
• Reduced hyperalgesia (higher opioid dose =
worsening of pain)
• Due to ceiling effect, virtually no potential for adults
to overdose on buprenorphine alone (unlike
OxyContin or Morphine)
• Potential for lower side effects (cognitive
dysfunction, constipation, etc.)
• Much lower risk of respiratory depression compared
to full mu agonists
• Potential anti-depressant effect due to Kappa
antagonist activity
6/7/2016
34
Schizophrenia
Schizophrenia
Huge Opportunity for LAIs
• 2.4 million adults with Schizophrenia
• $4-5B market opportunity in US only
• Latuda®, approved in 2010, reached >$1.0B in year
4 (fast uptake) depsite availability of 4 good generic
molecules
• Long-acting injectable (“LAI”) market reached $1.7B
in 2014
• 13% growth y-o-y for past two years, with
expected CAGR of 10-12% over next 5 years
• Currently ~18% patient share
6/7/2016
36
Risperidone six-month implant
• Risperdal well known and trusted product for schizophrenia
• 30% current patient share
• >$5B at peak (all indications)
• Key Opinion Leaders, patients and caregivers receptive to the concept of six-month implant
• Compliance is critical due to patient lack of insight
• “Game-changing”
• Long-acting risperidone family successfully penetrated oral market
• Consta (risperidone, every two weeks)/Sustenna paliperidone, (monthly) protected, priced at ~$1300 per
month, with sales of ~$1.4B
• J&J launched 3-month Sustenna in 2015
• Anticipated launch: Mid 2018
6/7/2016
37
Novel, Atypical Antipsychotic
ATI-9242 is only non 505(b)2, however active IND and early
human dosing already available
•
Designed to emulate best-in-class efficacy profile of
clozapine, while significantly limiting side effects
•
Has performed well in industry validated animal models
•
45 min half-life in humans, resolvable with long-acting
formulation
•
Attractive deal economics, single digit royalties
•
Significant market potential
6/7/2016
38
Other MedLaunch® Applications/Collaborations
• Tizanidine for MS spasticity targeted for Phase I/II in 1H 2016
•
Tizanidine is a short acting muscle relaxer shown to be as effective as other anti spasmodic agents
•
Requires dosing 3x/day
•
Use to treat chronic conditions such as multiple sclerosis, ALS, and Fibromyalgia
•
Daily dosing and chronic nature of disease it treats are a match with the MedLaunch technology
•
Animal studies slated to start in the 1H of 2016
• Research collaboration with large-pharma company around two NCEs
6/7/2016
39
Braeburn Intellectual Property Summary
Probuphine (Formulation)
•
U.S. Patent Issued: 7736665 (2024)
•
Canadian Patent Issued: 2487577 (2023)
CAM-2038 q1w and q4w (Formulation)
•
U.S. Patents Issued: 8545832 (2025); 8236755 (2026); 8236292 (2027)
•
U.S. Patent Pending: US-2015-0182522 (CAM-2038 q4w only)
•
Additional licensed/option territories: Patents issued and pending in Japan, Korea, and Canada
Risperidone (Formulation)
•
U.S. Patents Issued: 7858110, 8343528, 8357389, 8529936, 8658195 (2024); 7842303 (2027); 8303977, 8460274, 8784865 (2028); 9078900 (2029)
•
U.S. Patent Pending: US 2016-0030337
•
ROW: Over 100 patents issued and pending in 34 countries
ATI (Compound)
•
U.S. Patent Issued: 8093237 (2030)
•
ROW: Patents issued and pending in 25 countries
10/23/2015
41