No Slide Title v2… · [Section of Label: 2.5, 5.1] $2.5 Billion in 2014 U.S. Sales 5.5 Million...

29
Corporate Presentation (Nasdaq: COLL) June 1, 2015

Transcript of No Slide Title v2… · [Section of Label: 2.5, 5.1] $2.5 Billion in 2014 U.S. Sales 5.5 Million...

Page 1: No Slide Title v2… · [Section of Label: 2.5, 5.1] $2.5 Billion in 2014 U.S. Sales 5.5 Million Prescriptions % of Oxycodone Released 1 Hour1 17% 77% 0% 20% 40% 60% 80% 100% OxyContin

Corporate Presentation(Nasdaq: COLL)

June 1, 2015

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2

Forward-Looking Statements

This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”

“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or

outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and

uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example,

there can be no guarantee that we will obtain approval for Xtampza or any of our other product candidates from the U.S. Food and

Drug Administration (“FDA”) or foreign regulatory authorities; even if Xtampza is approved, we may not be able to obtain the label

claims that we are seeking from the FDA. Furthermore, we are subject to patent infringement litigation relating to Xtampza and

may, in the future, be subject to additional litigation relating to our other product candidates, which may be expensive to defend and

delay the commercialization of Xtampza or our other product candidates. Management’s expectations and, therefore, any forward-

looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors,

including the following: our ability to commercialize our product candidates; the size and growth potential of the markets for our

product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone

or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and

timing of our product development activities, studies and clinical trials; the success of competing products that are or become

available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for

our product candidates. These and other risks are described under the heading “Risk Factors” in the registration statement on

Form S-1 (commission file number 333-203208), which was declared effective by the Securities and Exchange Commission

(“SEC”) on May 6, 2015. Any forward-looking statements that we make in this press release speak only as of the date of this press

release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events

or otherwise, after the date of this press release.

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333

Developing Proprietary, Abuse-deterrent Pharmaceuticals

Leveraging our Drug Delivery Platform Technology

Proprietary DETERx Technology Platform®

Development Portfolio Focused on Chronic Pain

Potential significant therapeutic and abuse-deterrent benefits

Potential best-in-class technology

Each microsphere is extended-release and abuse-deterrent

– Lead program

˗ NDA filing accepted Feb. 10, 2015

˗ PDUFA goal date Oct. 12, 2015

˗ Developing commercial infrastructure for launch

Second opioid product clinic ready by year end

Methylphenidate out-licensing opportunity

Inactive components are

made of hydrophobic,

waxy materials

Microspheres

made of drug,

fatty acid and

waxes creates

ER properties

OXYCODONE

COL-172

OXYMORPHONE

COL-195

HYDROCODONE

COL-196

MORPHINE

COL-171

METHYLPHENIDATE

PRE-CLINICAL IND CLINICAL NDA

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Key 2015 Milestones

NDA Accepted for FDA Review

Raised $50M Mezzanine Round of Financing

Completed IPO Raising $80M

Initiated Commercial Build with Hiring of Key Leadership

4

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5

The Epidemic: Chronic Pain and Prescription Drug Abuse

Chronic pain represents a public health crisis of epidemic proportions¹˗ Over 100M people in the U.S. suffer from chronic pain; > heart disease, cancer and

diabetes combined

˗ Over $560BN in healthcare and productivity costs per year

¹ American Journal of Managed Care 2013. Prescription Opioid Abuse: Challenges and Opportunities for Payers. 2 IMS Data 2014.3 National Center for Health Statistics / CDC, National Vital Statistics Report, Final death data for each calendar year (June 2014).

Prescription opioids remain the primary treatment for chronic pain…˗ 29M TRx/year annually for extended-release (ER) and long acting (LA) opioids2

˗ OxyContin OP has a 20% U.S. market share (annual ER/LA TRx); $2.5BN U.S. Sales

… but deaths in the U.S. from prescription opioid overdoses have grown from ~4,000 in 1999 to ~16,000 in 20123

Abuse of painkillers cost payers over $72BN per year in direct healthcare costs1

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6

Significant Support for Abuse-deterrent Opioids

FDA Action

FDA final guidance “Abuse-Deterrent Opioids – Evaluation and Labeling”

FDA creating incentives for improved ADF technologies

Government

STOPP Act (Stop Tampering of Prescription Pills Act)

States starting to mandate that insurers cover abuse-deterrent opioids

Health Canada proposed regulations requiring all opioids to have abuse-deterrent properties

Industry Groups

Industry groups (BIO and PhRMA) lobby FDA to reject new opioid generics that aren’t ADF and remove non-ADF generics from the market where there is an alternative

“Ultimately, FDA looks forward to a future in which all or substantially all

opioid medications are less susceptible to abuse than the conventional

formulations that dominate the market today.”1

1FDA Federal Register, September 23, 2014. “Development and Regulation of Abuse-Deterrent Formulations of

Opioid Medications; Public Meeting”.

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Reformulated OxyContin OP Not Crush Resistant and Can Be

Easily Defeated by Household Tools

BLACK BOX WARNING

“Instruct patients to swallow OxyContin tablets intact. Crushing,

dissolving, or chewing the tablet can cause rapid release and

absorption of a potentially fatal dose of oxycodone.”

[Section of Label: 2.5, 5.1]

$2.5 Billion in 2014 U.S. Sales

5.5 Million Prescriptions

% of Oxycodone Released 1 Hour1

17%

77%

0%

20%

40%

60%

80%

100%

OxyContin OPIntact

OxyContin OPCrushed

% o

f O

xyco

do

ne

R

ele

ase

d

+ =

OxyContin OP

Tablet

$6.39 Pill Crusher Abuseable Fine Powder

in 16 Seconds

1Collegium in vitro dissolution study.

Implications for patient misuse and intentional abuse

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88

Reformulated OxyContin OP has Decreased Abuse by

Injection and Snorting — but Oral Abuse has Increased

Source: Butler, et al. 2012; NAVIPPRO 2nd Annual Scientific Meeting

89%

35%

61%

8%

52%

35%

14%

28%

3%

75%

0%

20%

40%

60%

80%

100%

Any non-oral Inject Snort Smoke Oral

Pe

rce

nt

of

Ab

use

rs

Original OxyContin Before (n=2,015)

Reformulated OxyContin After (n=490)

Initial findings on abuse rates and routes of administration among individuals assessed for

substance use treatment following introduction of reformulated OxyContin OP1

1Butler, et al. 2012; NAVIPPRO 2nd Annual Scientific Meeting

Abusers converted to oral abuse or defeated ADF mechanism and injected or snorted2

2Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States: Lessons Learned From OxyContin; JAMA

Psychiatry. doi:10.1001/jamapsychiatry.2014.3043; March 2015. (n=88)

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Types of Abuse-Deterrent Strategies

Limitations Examples

Particle size reduction leads

to significant increase in drug

release

Pre-treatment diminishes

gelling activity

OxyContin OP

(oxycodone ER)

Hysingla ER

(hydrocodone ER)

Potential for withdrawal

Potential for decreased pain

relief

Embeda

(morphine/naltrexone)

Targiniq

(oxycodone/naloxone)

Hard Tablet /

Gelling Features

Agonist /

Antagonist

Combination

Soft Hydrophobic

Microspheres

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DETERx: Potential Best-in-Class Abuse-deterrent

Technology

10

Microspheres made of drug, combined with fatty acid and

wax excipients creates ER properties

Microspheres are micron size, uniform in shape , soft and insoluble in water

Drug is homogeneously dispersed within

each microsphere

Drug binds chemically with

inactive components

DETERx® Design Elements

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Xtampza ER™ (oxycodone extended-release capsules) is being

developed 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.

Regulatory Status Studies to Support NDA

Fast Track Designation granted

505(b)(2) regulatory pathway

EOP2 and Pre-NDA meetings completed

Numerous FDA advice letters

NDA filing accepted Feb. 10, 2015

PDUFA goal date Oct. 12, 2015

Bioequivalence and bioavailabilityclinical trials

Phase 3 safety/efficacy clinical trial

Abuse-deterrent studies to support differentiated labeling

Supporting data for sprinkle and NG/G tube administration

REMS program consistent with classwide REMS

11

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is designed to be used safely by patients with

chronic pain with dysphagia (difficulty swallowing)

Sprinkle Food Studies Feeding Tube Studies

Chewing PK Data

0

10

20

30

40

50

60

0 2 4 6 8 10 12 14 16 18 20 22 24

Oxy

cod

on

e C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

DETERx Capsules Intact

DETERx Capsule Chewed

Source Data: CP-OXYDET-17

Xtampza Microspheres

Chewed

Xtampza Capsules

Soft Food PK Data

0

10

20

30

40

50

60

0 2 4 6 8 10 12 14 16 18 20 22 24

Oxy

cod

on

e C

on

cen

trat

ion

(n

g/m

l)

Hours

DETERx Capsules Intact

DETERx Microspheres Sprinkled on Food

Source Data: CP-OXYDET-27

Xtampza Microspheres

(Applesauce)

Xtampza Capsules

11M patients in U.S. with chronic pain with dysphagia

OxyContin OP cannot be used in this patient group

Inadequate treatment options

0

10

20

30

40

50

60

70

0 2 4 6 8 10 12 14 16 18 20 22 24

Oxycodone P

lasm

a

Concentr

ation (

ng/m

l)

Time (hrs)

Intact Capsules

Crushed Microspheres

Crushing PK Data

Source Data: CP-OXYDET-25

Xtampza Microspheres

Crushed

Xtampza Capsules

Large Unmet Medical Need

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131313

Study Design

vs Placebo, randomized withdrawal design

12 week study in patients with moderate to severe chronic lower back pain

Opioid naïve and experienced subjects (N=389 randomized)

Rescue medication: acetaminophen

Pivotal Phase 3 Efficacy and Safety Clinical Trial

13

Results

Achieved primary and secondary endpoints

Sensitivity analyses all significant

Safe and well tolerated

1 FDA approved Collegium’s SAP for Study CP-OXYDET-08.

0.29

1.85

0.0

0.5

1.0

1.5

2.0

DETERx Placebo

Ch

an

ge

fro

m B

as

eli

ne

p<0.0001

Change from Randomization Baseline to Week 12 / Early Discontinuation – Average Daily Pain Intensity Score1,2

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Comprehensive Evaluation of vs OxyContin OP

Developed to be Consistent with FDA Guidance1

1 FDA Final Guidance, “Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling”, issued in April 2015.

Category 1

Lab based in vitro

manipulation and

extraction studies

Category 1

Laboratory based in

vitro manipulation

and extraction

studies

Category 2

Pharmacokinetic

Clinical Trials

Category 3

Human Abuse

Potential Clinical

Trials

• Numerous physical and

chemical manipulation

studies

• Numerous route specific

extraction studies

Five Clinical Trials Two Clinical Trials

CP-17 (oral)

CP-19 (nasal)

CP-21 (nasal)

CP-24 (oral)

CP-25 (OxyContin)

CP-21 (nasal)

CP-24 (oral)

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1515

Category 1: Extensive Evaluation Completed vs.

OxyContin OP

Experiment Objective

Ma

nip

ula

tion

Ph

ysic

al

Particle Size

Reduction

(PSR) studies

Effect of household tools on increasing drug

release (validated in independent third party

laboratory)

Ch

em

ica

l

Extraction

studies

Drug released into solvents under multiple

conditions

Ro

ute

Sp

ecific

IVIn

jection

Small volume

extraction for IV

injection

Extraction of drug into injectable amounts of water

Direct injection

and melting

Ability to suspend in liquid and inject or melt and

inject

SyringeabilityDrug passed through syringe after crushing and

exposing to water

Sm

okin

g Simulated

smoking abuse

study

Drug vaporized for the purpose of smoking

Summary of laboratory based in-vitro manipulation and extraction studies

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1616

Category 1: Attempts to Inject

16

Attempt to Melt and InjectAttempt to Suspend in Liquid and Inject

18 gauge

25 gauge

27 gauge

Negligible amounts of microspheres pass through the largest needle

Melt clogs syringe

Xtampza melted and

attempted to draw into

syringe

Xtampza quickly

solidifies and clogs

needle

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Category 1: Attempts to Extract and Inject vs.

OxyContin OP

Injecting OxyContin OP“Its super easy to bang the new OP formula. U just file it down to a powder, put on

spoon, burn till it turns brown, add water and stir. U can then place a small piece of

cotton in it and draw up. Same high as before..”*http://www.medschat.com/Discuss/NEW-OXYCONTIN-OPS-209675_s2.htm

Injection Study: versus OxyContin OP (40 mg strength)

OxyContin label warning that injection of the inactive ingredients can result in local tissue necrosis, infection, and increased risk of heart disease

1 Crushing method identified as most effective for each product in PSR study;

Extraction following boiling temperature in water.

2.617.1

0

20

40

60

80

100

Xtampza OxyContin OP

% D

rug

Re

lea

se

d Crushed1

8.4

83.7

0

20

40

60

80

100

Xtampza OxyContin OP

% D

rug

Re

lea

se

d

Crushed, Microwave2

2 Extraction in boiling water following pretreatment of solid powder in

microwave after 8 minutes of exposure.

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0

10

20

30

40

50

60

70

80

IR OxycodoneControl

Xtampza Intact Xtampza Crushed

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

0

20

40

60

80

100

120

140

IR OxycodoneControl

XtampzaIntact

XtampzaChewed

XtampzaCrushed

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

18

Category 2: Oral and Nasal PK Clinical Trials Demonstrate

xxxxxxxx Abuse-deterrence

1. CP-OXYDET-17; Oral tamper PK study, naltrexone blocked subjects (N=44).

2. CP-OXYDET-21; Intranasal HAP study, non-naltrexone blocked subjects (N=36).

3. Bioequivalence as defined as 90% Confidence Interval within 80% to 125%.

Cmax (ng/mL)

Oral PK1 Nasal PK2

Cmax (ng/mL)

Bioequivalent3

Cmax decreases

when microspheres are snorted

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Category 2: vs. OxyContin OP in PK Clinical

Trial; OxyContin OP Demonstrates “Dose Dumping”

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

Crushing results in

loss of ER properties

OxyContin OP1 Xtampza1

1. CP-OXYDET-25 was a randomized (n=36), open-label, active-controlled,

5-period, naltrexone-blocked, healthy subject, crossover study.

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12O

xyco

do

ne

Pla

sma

Co

nce

ntr

atio

n (

ng/

ml)

Time (hrs)

Intact and Crushed curves

Bioequivalent with similar Tmax

BLACK BOX WARNING

“Instruct patients to swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet

can cause rapid release and absorption of a potentially fatal dose of oxycodone.” [2.5, 5.1]

Treatment Arm Cmax Tmax

OxyOP Intact Tablet 64.9 5.0

OxyOP Crushed Tablet 78.4 1.75

IR Crushed Tablet 79.4 1.75

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

OxyContin Intact

OxyContin Manipulated

IR Manipulated

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

Treatment Arm Cmax Tmax

DETERx Intact Capsule 67.5 3.5

DETERx Crushed Microspheres 62.9 4.0

IR Crushed Tablet 79.4 1.75

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

DETERx Intact

DETERx Manipulated

IR Manipulated

Xtampza Intact Capsule

Xtampza Crushed Microspheres

IR Crushed Tablet

Treatment Arm Cmax Tmax

OxyOP Intact Tablet 64.9 5.0

OxyOP Crushed Tablet 78.4 1.75

IR Crushed Tablet 79.4 1.75

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

OxyContin Intact

OxyContin Manipulated

IR Manipulated

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

Treatment Arm Cmax Tmax

OxyOP Intact Tablet 64.9 5.0

OxyOP Crushed Tablet 78.4 1.75

IR Crushed Tablet 79.4 1.75

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

OxyContin Intact

OxyContin Manipulated

IR Manipulated

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12

Oxy

cod

on

e P

lasm

a C

on

cen

trat

ion

(n

g/m

l)

Time (hrs)

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Category 2: vs OxyContin OP in PK Clinical Trial:

Abuse Quotient (Cmax/Tmax)

AQ (Cmax/Tmax) provides a rough measure of “rate of rise” in plasma concentration

AQ for OxyContin OP crushed and IR crushed are similar

Error bars = standard deviation

0

20

40

60

80

100

120

DETERx Intact DETERx Manipulated OxyContin Intact OxyContin Manipulated IR Manipulated

AQ

(n

g/m

l/h

r)

Lower than Baseline

~4x Baseline

Xtampza Crushed OxyContin Crushed IR Crushed

Source: data from CP-OXYDET-25 study.

Xtampza Intact OxyContin Intact

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40

50

60

70

80

90

100

Dru

g L

ikin

g E

max

(Peak E

ffect)

2121

Category 3: Intranasal and Oral Human Abuse

Potential (HAP) Clinical Trials (“Drug Liking”)

21

40

50

60

70

80

90

100

CrushedDETERx IN

IntactDETERx Oral

IR OxycodoneIN

Placebo

Dru

g Li

kin

g Em

ax(P

eak

Effe

ct)

Error Bars = ± Standard error of the mean

Drug Liking – Emax (Peak Effect)

1Data from CP-OXYDET-21 clinical trial (n=36). 2Data from CP-OXYDET-24 clinical trial (n=36).

Drug Liking – Emax (Peak Effect)

Intranasal HAP1 Oral HAP2

P= 0.037

P=0.0292P< 0.0001

Xtampza

Crushed

Snorted

Xtampza

Intact

Oral

IR Oxycodone

Crushed

Snorted

P<0.0001

Placebo

Error Bars = ± Standard error of the mean

PlaceboIR Oxycodone

Crushed

Xtampza

Intact

Xtampza

Chewed

P< 0.0001

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Label Differentiation Strategy

Section of Label Potential Differentiation

Dosage and

Administration

Additional language: Open capsule and sprinkle, administer via

NG/G tubes

Pharmacology Addition of PK data from Abuse-deterrent sprinkle clinical trials

Black Box

Warning and

Precautions

Throughout

Label

Removal of the following: Instruct patients to swallow OxyContin

tablets intact. Crushing, dissolving, or chewing the tablet can cause

rapid release and absorption of a potentially fatal dose of

oxycodone*.

* Included in label sections black box, 2.5, 5.1, 5.2, 17

Drug Abuse

Label will be consistent with FDA Abuse-Deterrent Guidance:

• Category 1 In Vitro Claims1

• Category 2 PK Claims (Oral and Nasal)

• Category 3 HAP Claims (Oral and Nasal)2

Other• Removal of warnings about difficulty swallowing, risks of IV

injection, etc.

1. OxyContin label includes limited in vitro tamper data.

2. OxyContin label includes data from only one intranasal human abuse potential study. The data did not show statistically significant

reduction compared with IR (i.e. original OxyContin or oxycodone HCL powder).

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Will Not Take or Prescribe

OxyContin OP

23

Product Positioning – vs OxyContin OP:

Early Adoption Targets

Superior Abuse-

Deterrence / Safety

1

Cannot Swallow or

Difficulty Swallowing

Tablets

2

3

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Compelling Market Opportunity

Potential large revenue

opportunity in the

existing oral ER opioid

market and dysphagia

market

Safety

Ease of Swallowing

Abuse-deterrence

Effective pain relief

Potential Best-in-Class

Abuse-Deterrent

Technology

Potentially the Only Abuse-

Deterrent ER Opioid Addressing

Patients with CPD

Chronic Pain

PopulationDysphagia

PopulationCPD

Candidates

for ER

Opioids

29 Million TRx per year 11 Million Patients in the U.S.

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Large ER/LA Opioid Market / Narrow Prescriber Focus

ER/LA Opioids

29 Million TRx / $6BN U.S. Sales in 2014

Products

Sales

Avinza, Kadian,

MS Contin,

Generic ERs

Duragesic,

Generic ERs OxyContin

OPANA ER,

Generic ERsGeneric LAs Butrans

Zohydro, Ultram,

Nucynta, Exalgo,

Generics ERs

$1.1BN $1.2BN $2.5BN $80M $470M $210M $310M

Source: 2014 IMS Data.

Chronic Pain & Dysphagia

Segments

Morphine Fentanyl Oxycodone Methadone Oxymorphone Buprenorphine Other

10.1M

6.5M5.5M

3.6M

1.0M 0.7M 1.0M

Prescribers

(Deciles 6-10)10,000 8,500 3,500

Significant overlap in prescribing base

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Commercialization Strategy

Preparing for potential Q1 2016 U.S. commercial launch

> Key commercial leadership in place

> Launch planning process underway

Launch with a sales team of approximately 100-125 reps targeting the

approximately 10,000-12,000 prescribers that write more that 50% of the

branded ER opioids

Clinically focused specialty sales force targeting institutions focused on CPD segment

> Target palliative care, long-term care, hospital-based clinics

Achieve broad Tier 3 payer coverage on Commercial plans and

aggressively contract with Medicare and Medicaid

> Co-pay reduction programs

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Strong IP Portfolio

27

Nine patents covering the DETERx® technology platform

˗ Seven U.S. patents are expected to be listed in Orange Book atapproval

˗ Additional three issued patents in Ex-US territories: Japan, Australiaand Canada

Issued patents are projected to expire in 2025

Eight additional patent applications in prosecution with the USPTO and International patent offices that could broaden and extend coverage beyond 2030

Proprietary manufacturing processes

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Hatch-Waxman Litigation Status

FTO opinion completed

Collegium submitted Paragraph IV certification to Purdue for all 11 Orange Book listed patents

˗ Non infringement position

Purdue filed suit in March 2015

˗ 3 currently invalid Orange Book listed patents

˗ 1 non-Orange Book listed patent

Collegium is extremely confident in its “non-infringement” position and intends to vigorously defend its position

28

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Investment Highlights

Proprietary Manufacturing

Process

• Proprietary processes support

microsphere matrix formulation

• Commercially scalable

Strong IP Portfolio

• Patents cover DETERx platform

technology

• Issued patents up to 2023 and

2025

• Additional patent applications

extend coverage up to 2030

Platform Technology

• Additional product opportunities

• Target 2nd product candidate

entering clinic Q1 2016

• Licensing opportunities (e.g.

ADHD)

International Opportunities

• Near-term opportunity to

expand in Canada, Japan,

Europe and Australia

• Future opportunities in Latin

America and Asia

Differentiated Product

• Superior abuse-deterrence to

OxyContin OP as demonstrated

in clinical trials

• Opportunity to address large

unmet medical need in patients

with CPD

Business Development

• Identify and license, co-promote

or acquire products being

developed for pain indications

and other complementary

products