Investor Presentation1).pdf · Investor Presentation June 4, 2015 Jefferies Global Healthcare...

Investor Presentation

June 4, 2015 Jefferies Global Healthcare Conference

Frank Condella Chief Executive Officer

George O. Elston Chief Financial Officer

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Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," or similar expressions, and which are generally not historical in nature. These include all statements relating to expected financial performance and future business or product developments. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Juniper does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law. For a discussion of certain risks and uncertainties associated with Juniper's forward-looking statements, please review Juniper’s reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2014.

© 2015 Juniper Pharmaceuticals, Inc.

Safe Harbor

2 04 June 2015

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Juniper Pharmaceuticals Overview

Specialty pharmaceutical company • In-house formulation and manufacturing expertise

Growing revenues / Strong balance sheet • CRINONE® • Service business

Proprietary drug development • Novel delivery technologies

• Bioadhesive delivery system (BDS)

• Segmented intra-vaginal ring (IVR)

• COL-1077 (10% lidocaine vaginal gel)

• Patient enrollment in Phase II study to begin June 2015

04 June 2015 © 2015 Juniper Pharmaceuticals, Inc. 3

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Experienced Management Team

© 2015 Juniper Pharmaceuticals, Inc. 4

Frank Condella, BS Pharm, MBA Chief Executive Officer

30+ years of experience in life sciences industry

George O. Elston Chief Financial Officer

20+ years of experience in life sciences industry

Nikin Patel, MRPharmS, PhD Chief Operating Officer

15+ years of pharmaceutical industry experience

Bridget Martell, MD, MA Chief Medical Officer, VP Clinical

15+ years of pharmaceutical and medical experience

Shen Luk, BSc, PhD Chief Scientific Officer

20+ years of technical expertise in pharmaceutical analysis & formulations

Claire Madden-Smith, BSc, PhD VP, Commercial Services

15+ years of contract research organization business and technical experience

04 June 2015

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Building Proprietary

Drug Pipeline

Growing CRINONE® Franchise

Expanding Service

Business

Value Creation Strategy Taps Multiple Synergies


INCREASED ENTERPRISE

VALUE

04 June 2015

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Proprietary Drug Development

© 2015 Juniper Pharmaceuticals, Inc. 6 04 June 2015

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Selectively develop therapeutics for women’s health

Initially utilize “505(b)(2)” approval pathway

Utilize patented drug delivery technologies: IVR & BDS

Leverage in-house expertise: Formulation -- Drug development -- Manufacturing


Proprietary Drug Development Strategy

7 04 June 2015

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Martyn Davies, BSc, PhD, FRPharmS, CChem, FRSC • Chairman • Professor of Biomedical Surface Chemistry, University of

Nottingham School of Pharmacy, (UK) Ginger Constantine, MD

• Rheumatologist; former Women’s Health Head at Wyeth Bill Crowley, MD

• OB/GYN, reproductive endocrinology specialist; IVR co-inventor Bob Langer, ScD

• Distinguished and highly renowned engineer and inventor; IVR co-inventor

Dan Shames, MD, FACS • Urologist; former Division Director FDA in Women’s Health


Scientific Advisory Board

8 04 June 2015

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Delivery Technology: Bioadhesive Delivery System (BDS) Facilitates binding to mucosal surfaces using

proprietary technology Allows controlled & sustained release of drug Discharged upon normal cell turnover

• 3-5 days in vaginal epithelium • Up to every 24 hours for oral mucosa

Gel & tablet formulations Strong history with CRINONE®, RepHresh® &

Replens® vaginal gels Utilized in COL-1077

© 2015 Juniper Pharmaceuticals, Inc. 9 Replens® and RepHresh® are registered trademarks of Church & Dwight Co. 04 June 2015

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COL-1077 Sustained-release 10% Lidocaine Vaginal Gel Target Market:

• Vaginally administered acute use anesthetic for minimally invasive gynecological procedures

Proprietary Formulation: • Sustained-release 10% lidocaine HCl using proprietary BDS gel • Leverages data from previous Phase I and II studies • Strong safety profile • Manufactured in-house by Juniper Pharma Services

Exclusivity: • Patented formulation (through 2024) • Hatch Waxman three-year exclusivity • Other barriers to generic entry


6 May 2015 11 © 2015 Juniper Pharmaceuticals, Inc.

COL-1077 Opportunity: Minimally Invasive GYN procedures

5-6 million procedures

per year (U.S.)1

Tenaculum placement

Transcervical instrument insertion

Physical tissue

sampling

Treatment

1) Sources available on request

• Clamping & positioning uterine cavity

• Hysteroscopy • IUD insertion

• Endometrial ablation

• Endometrial biopsy

Mild discomfort to severe pain Need for analgesia before and after procedures Post-procedural pain and cramping can continue

for hours or days

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Duration Issue Potential Side Effects Administered By

Rx Topical “Caines” (Benzocaine, Lidocaine,

Prilocaine) Short acting Minimal relief Local site

irritation

Physician (lengthens overall procedure cycle

times)

Paracervical Nerve Block

Short acting; Varies by API Painful injection Bleeding

Infection Physician

NSAIDS Short acting Ineffective for

post-procedural cramping

Increased bleeding risk Patient

Opioids Varied Abuse liability

Nausea Vomiting

Constipation Sedation

Patient


GYN Procedure Pain: Current Analgesics Inadequate

12 04 June 2015

Primary Research Two-thirds of OB/GYNs found the attributes of COL-1077 favorable

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187 Patients in 4 Clinical Trials Safety Summary Well tolerated No safety concerns Maximum concentration in serum < IV lidocaine

Vasopressin-induced Cramping Study Statistically significant decrease in: Cramping Uterine pressure Uterine cramping Reported pain


COL-1077: Previous Clinical Trial Experience

13 04 June 2015

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Design Multicenter, randomized,

double-blind, placebo-controlled

Women undergoing pipelle-directed endometrial biopsy with tenaculum placement

150 patients at 15 U.S. sites

Single dose of COL-1077 self-administered by patient at home before procedure

Endpoints Primary: Reduction in pain

intensity at the time of endometrial biopsy

Secondary: Reduction in post-procedural pain timepoints

Patient-related outcome measures will also be developed for health economic endpoints

04 June 2015 14 © 2015 Juniper Pharmaceuticals, Inc.

COL-1077: Phase II Clinical Study

Study results expected mid-2016

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Long-standing relationship between co- inventor Dr. Robert Langer (MIT) and JPS (f/k/a Molecular Profiles)

Alignment of both parties’ interests and criteria • Proprietary, differentiated IVR a strong fit with JNP’s focus & experience • JNP’s commitment to WHC & strong development capabilities to

advance IVR candidates

Exclusive license to IVR worldwide rights Key drug delivery platform for proprietary product pipeline IVR already studied with progesterone, estradiol & leuprolide Evaluating several product concepts addressing large market

opportunities


Delivery Technology: Segmented Intra-vaginal Ring (IVR)

15 04 June 2015

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Juniper Segmented IVR Membrane Rings

Design Homogeneous cross section of drug

Drug-containing core using rate-controlling membrane

Molecular Weight Limitation? NO Yes

Drug Dumping from Breakage of Ring? NO Yes

Manufacturing Simplified Complex


Segmented IVR Benefits

16 04 June 2015

Unique polymer

composition

Segmentation capability

Delivery of one or more drugs at different dosages & release rates

within single ring system

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GYN Endocrine

Endocrine – Bone

OB / Reproductive


Therapeutic Target Areas Leveraging BDS and IVR technologies

17 04 June 2015

SAB Reviewed areas of “low-hanging fruit”

product opportunities

Rheumatologic

Uro- Gynecological

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Revenue Sources


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CRINONE® 8% (progesterone gel): largest single revenue source

Exclusive agreements with Actavis and Merck Serono through mid-2020

Low double-digit revenue growth

Product sales to Merck Serono generate ~40% margin on average

10% royalty on Actavis sales in U.S.


Growing Franchise

04 June 2015

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CRINONE® Progesterone Vaginal Gel


Most Major Markets Covered

Markets CRINONE in 60+ countries Strong in-market growth in most

countries due to active promotion Expansion into new markets

underway

In-market growth continuing through active promotion

Global Franchise

04 June 2015

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$18.5

$22.1

$17.5

$-

$5.0

$10.0

$15.0

$20.0

$25.0

2012 2013 2014 2015E


CRINONE Growth Profile

Ex-U.S. CRINONE Revenue

U.S. Royalty Revenue U.S. Drivers Ongoing promotion by Actavis’

specialty sales force Growth in fertility treatments

Ex-U.S. Drivers Revenue reflects timing of

shipments to Merck Serono Revenue growth drivers:

• In-market expansion • New market entry

(1) Inventory build up Q1-Q3 2013 ahead of routine license renewal period in large market (2) License renewal period concluded 2H 2014

$3.1 $3.5

$3.9

$0.0$1.0$2.0$3.0$4.0$5.0

2012 2013 2014 2015E

04 June 2015

Q1 (A)

Q1 (A)

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Pharmaceutical Development and Manufacturing

22 04 June 2015

Fee-for-Service Model

Self-Funded, In-House Center of Excellence for

New Product Development

World-class pharmaceutical

development

Acclaimed Formulation

expertise

Science-led approach

State-of-the art facilities

Industry alliances to

accommodate larger projects

Clinical supply manufacturing

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Industry trend toward outsourced development • JPS’s reputation is impeccable, technology offering is broad

and comprehensive, and expertise is world-class

Over 70% of new drugs are classed as difficult to formulate1

• JPS’s forte

Clients range from Large Pharma to development stage biotech companies • JPS strives to attract, grow, and maintain long-term client

relationships


Juniper Pharma Services: Growth Factors

23 04 June 2015

1: Source: Lipp, R. The Innovator Pipeline: Bioavailability and Advanced Oral Drug Delivery Opportunities. American Pharmaceutical Review. 16 (3): 10-16 (2013)

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Financials


$0.0

$2.0

$4.0

$6.0

$8.0

$10.0

$12.0

Q12013

Q22013

Q32013

Q42013

Q12014

Q22014

Q32014

Q42014

Q12015

Other Royalties

Other revenues

Service revenues

Product revenues

Royalties

Diverse Revenue Stream (in millions)

Inventory build-up by Merck Serono ahead of routine license renewal period

License renewal period


$6.3

$8.0 $7.1

$7.8 $7.0 $6.9

$11.5

$7.3

$8.3

$0.9

Q1 2014 Q1 2015

Financial Highlights – Q1

$7.0 $8.3

Q1 2014 Q1 2015

Total Revenues (in millions)

$0.2 ($0.7)

Q1 2014 Q1 2015

$2.9 $4.3

Q1 2014 Q1 2015

Cash Flows from Operations (in millions)

Operating Expenses (in millions)

Net Income (in millions)

($0.2)


│ │ © 2015 Juniper Pharmaceuticals, Inc. 27

Financial Facts

Nasdaq: JNP Shares Outstanding1 10.8 M

Average1 Preferred Shares @ $ 6.23 0.1 Warrants* @ $10.80 0.5 Options @ $ 6.98 0.9 Fully Diluted Shares 12.3 M

Closing Price2 $7.97

Market Capitalization2 $86.1 M

2014 Revenues $32.5 M

Cash & Equivalents (3/31/15) $16.3 M

1 Share count and average pricing as of May 5, 2015. 2 Share price and market cap as of June 3, 2015. * Warrants expire July 2015 04 June 2015

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Initiate COL-1077 Phase II study Q2 ‘15 Additional product candidate(s) 2H ‘15 Data publication 2H ‘15

• Vasopressin study: COL-1077 • Aggregate PK data: COL-1077 • Phase I study: IVR delivery of leuprolide

CRINONE approvals: Europe 2H ‘15 COL-1077 enrollment update Q4 ‘15


Near Term Catalysts

04 June 2015

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Strong revenue and cash flow from core operations

Building a proprietary product pipeline • COL-1077 (10% lidocaine gel) into clinic – June 2015 • At least one additional product candidate in 2015

Leveraging self-funded R&D arm • World-class pharmaceutical development services • Supports early development through Phase II

manufacturing

Strong balance sheet


JNP: Positioned for Growth

04 June 2015

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Katja Buhrer MBS Value Partners T: 212.661.7004 [email protected]


Investor Relations Contact

04 June 2015

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