Juniper Pharmaceuticals (JNP) 8-K Third Quarter 2007 Financial Results

Results of the
Three- and Nine-months Periods
ended September 30, 2007

Columbia Laboratories, Inc.

November 8, 2007

2

Under The Private Securities Litigation
Reform Act Of 1995

Safe Harbor Statement

Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.’s
expectations made in this presentation constitute forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such
forward-looking statements involve certain risks and uncertainties. Those statements include statements
regarding the intent, belief or current expectations of Columbia Laboratories and its management team.
Investors are cautioned that any such forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and that actual results may differ materially from those projected in the
forward-looking statements. Given these uncertainties, investors should not place undue reliance on these
forward-looking statements. Factors t
hat might cause future results to differ include, but are not limited to, the
following: the successful marketing of CRINONE® 8% (progesterone gel), PROCHIEVE® 8% (progesterone
gel), PROCHIEVE 4% (progesterone gel), and STRIANT® (testosterone buccal system) in the U.S.; the timely
and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea,
and new indications for current products, including PROCHIEVE 8% to reduce the risk of preterm birth in
women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including
the clinical studies for our vaginal lidocaine product candidate and the planned Phase III study of PROCHIEVE
8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications
for current products by the FDA and international regulatory agencies, the impact of competitive products and
pricing; competitive economic and regulatory f
actors in the pharmaceutical and healthcare industry; general
economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s
reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to
publicly update any forward-looking statements.

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Agenda

•IntroductionBob Mills

Chief Executive Officer

•Financial results Jim Meer

Chief Financial Officer

•Business update Bob Mills

—CRINONE business

—R&D initiatives

•Short Cervix Data George Creasy, MD

VP - Clinical Research

•Q&A Period

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	Q3 2007	Q3 2006
Net Revenues	$7.3	$4.9
Gross profit	5.6	2.8
Loss from operations	(1.9)	(2.3)
Net loss	(3.9)	(2.6)

$ in millions

Financial Highlights: Three Months

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	9 months 2007	9 months 2006
Net Revenues	$21.3	$15.0
Gross profit	14.7	8.7
Loss from operations	(5.6)	(6.3)
Net loss	(11.4)	(7.8)

$ in millions

Financial Highlights: Nine Months

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CRINONE / PROCHIEVE

•Progesterone sales were $5.0 million in Q3 ’07

—17% increase over Q2 ‘07

—51% increase over Q3 ‘06

•Sales force expansion to 30 representatives

—7 new west coast territories filled

—Target 560 reproductive endocrinologists

—Target 2300 Ob/Gyn’s with infertility practices

•September ‘07 agreement with DesignRxclusive to
increase exposure to cash-paying infertility patients

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PROCHIEVE 4% DEAL

•Licensed U.S. marketing rights to Ascend
Therapeutics

—5-year term

—Begins Jan. 1, 2008

•Why partner with Ascend?

—Broad sales force reach

•100 reps calling on 14,000 MDs likely to write
PROCHEIVE 4% for secondary amenorrhea

•CBRX WHC marketing 100% infertility and
pregnancy support-focused

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5.6 million women frequently miss work

Lidocaine for Dysmenorrhea

•Phase II clinical trial design

—Randomized, double-blind, placebo-controlled cross-over study

—75-patients

•Timeline

üInitiated studyJune ‘07

üBegan enrollment August ‘07

üAdded 2 additional sitesOctober ‘07

—Complete enrollment Q1 ’08

—Announce resultsQ2 ’08

—File NDA with FDA 1H ‘09

PROCHIEVE 8% for the Prevention
of Preterm Birth

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Presentation Outline

•Background

•Trial design

•Baseline characteristics

•Study Results

•Secondary Results - Short Cervix Analyses

•Infant Outcomes

•Fonseca Short Cervix Result

•Conclusions

Background

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* Based on the c-index (the area under the receiver-operating curve)

Risk Factors for Preterm Birth (PTB) 
To &Nicolaides et al 2006 Ultrasound Obstet Gynecol

•39,284 cases with 22-24 week ultrasound and delivery date

•The highest magnitude of accuracy* for predicting delivery
< 37 weeks

—Short Cervix 61.2%

—Adding previous PTB history 65.6%

—Adding previous PTB history and
age, ethnicity, BMI, cervical surgery 66.7%

Short cervix was the most important single predictor of PTB 

Trial Design

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Study Endpoints

•Primary

—Reduction in the frequency of preterm birth <32 wks

•Secondary

—Reduction in the frequency of preterm birth <37, 35,
and 28 wks

—Neonatal morbidity

—Delay in delivery after treatment with tocolysis

—Reduction in the frequency of preterm birth in short
cervix patients

•Safety Assessments

—Maternal adverse events

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Summary of Study Design Features
Key Difference from Prior Studies

•Double-blind, placebo-controlled, multicenter

•1:1 randomization ratio

•Previous spontaneous preterm birth (<35 weeks)

•Baseline cervical length on all subjects

•Exclusion:

—Multiple gestations

—Cerclage being considered

—Contraindications to PROCHIEVE

Baseline Characteristics

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Very high risk 

study population 

Results (ITT Population) -
Baseline Characteristics 

•Baseline characteristics of ITT population equivalent in
PROCHIEVE & placebo arms for all criteria

•Cervix Length: 3.7 cm

•Compliance: 96%

•Median GA at Start: 19 weeks

•GA of Previous PTB: 30 weeks

•Previous PTB < 32 wks: 56%

•≥ 2 prior PTBs: 25%

Study Results

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Study Results

•Primary result: no apparent treatment effect in women
with only a history of PTB (not responders to
progesterone)

•Secondary results: Women with short cervix at baseline
are responders to treatment

Secondary Results:
Short Cervix Analyses

DeFranco Publication

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PROCHIEVE

Placebo

CL <3.2 cm; n=172

(83 PROCHIEVE, 89 Placebo)

CL ≥3.2 cm; n=437

(226 PROCHIEVE, 211 Placebo)

n=611 

(309 PROCHIEVE, 302 Placebo)

Kaplan Meier Curves
for Time to Delivery: 

Overall and by
Quartiles of Cervical
Length at Baseline

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The Kaplan-Meier method was used for calculation 

(Wilcoxon p = 0.37, log-rank p = 0.34)

PROCHIEVE (n=83)

Placebo (n=89)

CL ≤ 3.2 cm (n=172)

Probability of patients with baseline cervical length             
≤ 3.2 cm (first quartile) remaining undelivered
according to treatment group

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The Kaplan-Meier method was used for calculation 

(Wilcoxon p = 0.043, log-rank p = 0.057) 

PROCHIEVE (n=58)

Placebo (n=58)

CL ≤ 3.0 cm (n=116)

33 investigators

Probability of patients with baseline cervical length              
≤ 3.0 cm remaining undelivered according to treatment
group

24

PROCHIEVE (n=19)

Placebo (n=27)

Fishers Exact Test @ ≤ 32 weeks:

0% PROCHIEVE versus 29.6% Placebo (p = 0.014)

CL < 2.8 cm (n=46)

22 investigators

Probability of patients with baseline cervical length                
< 2.8 cm remaining undelivered according to treatment
group

Infant Outcomes

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  p=0.016

All Cervical Lengths

CL < 2.8 cm

%

CL ≤ 3.0 cm

%

%

p=0.077

p=0.16

Placebo PROCHIEVE

Admissions to the NICU

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#

#

All Cervical Lengths

CL < 2.8 cm

#

CL ≤ 3.0 cm

p=0.026

p=0.05

p=0.013

Placebo PROCHIEVE

Average Infant NICU Days

28

%

All Cervical Lengths

CL ≤ 3.0 cm

%

%

p=0.061

p=0.09

CL < 2.8 cm

P=0.8

Placebo PROCHIEVE

Respiratory Distress Syndrome (RDS)

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All Cervical Lengths

CL ≤ 3.0 cm

CL < 2.8 cm

Placebo PROCHIEVE

Average Birth Weight (grams)

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	Placebo	PROCHIEVE 8%
Gestational age at delivery	35.5 weeks	37.1 weeks
Admissions for PTL	7 (26%)	6 (32%)
Time to delivery after therapy for PTL	10 days	43 days

(All Randomized Patients)

Secondary Outcomes in Patients with
Baseline CL ≤ 2.8 cm

Fonseca Short Cervix Result

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Treatment:

Vaginal micronized progesterone 

24-34 weeks gestation

Perinatal Outcome:

No significant improvement

Gestational Age (days)

Conclusions

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Conclusions of Largest Singleton Study to
Prevent Preterm Birth with Progesterone

•The efficacy of progesterone to prevent PTB in women
with only a history of a prior PTB is inconclusive

•Vaginal progesterone prevents PTB in women with
mid-pregnancy cervical shortening

—Supported by two recent trials (Fonseca, DeFranco)

•Vaginal progesterone gel initiated at 18-23 weeks
gestation in patients with a short cervix is associated
with improved neonatal outcomes

—The first trial with this finding

•Vaginal progesterone gel is not associated with
miscarriage

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Prochieve's Role in Extending Gestation: New
Advances, New Therapies (PREGNANT) Study 

•Phase III Study Design

—Randomized 1:1, double blind, placebo controlled

—300 women with cervical length between 1.0 - 2.0 cm

—15 - 25 centers (international)

—Primary outcome: a reduction in preterm births ≤ 32 weeks
vs. placebo

—Trend in improved infant outcomes

•Timeline

—Initiate studyQ4 ‘07

—Begin patient enrollment Q1 ‘08

—Complete patient enrollment mid - ‘08

—Last birth Q4 ‘08 / Q1 ‘09

—Announce results Q1 ‘09

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$1.6 Billion Total Market Opportunity 

$250 million market
potential

4.1 Million Births
Annually

>2.5 - 3.0 cm
(20%)

$1.05 billion 

market potential

>2.0 - 2.5 cm
(5.25%)

1.0 - 2.0 cm
(4.75%)

$275 million market
potential

16 weeks  X  $80.0 week  = 

$1,280 per patient

PROCHIEVE 8% U.S. Market Opportunity 

Question and Answer Period 

Columbia Laboratories, Inc.