EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 exhibit_99-1.htm


EXHIBIT 99.1
 
 
June 2015
 
 

 
Disclaimer
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Foamix, they are forward-looking
statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks,
uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be
materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such
as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the
negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not
limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for
our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of
patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; (v) the
timing or likelihood of regulatory filings and approvals; and (vi) our revenues under our agreements with our licensees, including Bayer, Actavis
and Merz.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, various factors may cause differences
between our expectations and actual results, including, but not limited to, unexpected safety or efficacy data, unexpected side effects observed
during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition,
changes in the regulatory environment for our product candidates and our need for future capital, the inability to protect our intellectual
property, and the risk that we become a party to unexpected litigation or other disputes. You should read the documents filed by Foamix with
the SEC, including our prospectuses, the Risk Factors set forth therein and the documents filed as exhibits to our registration statements, of
which the prospectuses are a part, completely and with the understanding that our actual future results may be materially different from what
we expect.  You may obtain those documents by visiting EDGAR on the SEC website at www.sec.gov. Except as required by law, we assume no
obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those
anticipated in the forward-looking statements, even if new information becomes available in the future.
The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be
construed as an endorsement of the foam technology or product candidates of Foamix or this offering.
This document will not be left behind after this presentation and by accepting this document and attending the presentation you agree to be
bound by the foregoing limitations.
2
 
 

 
Highlights
3
Including Bayer, Actavis and Merz
Collaborations with leading pharma companies
Proprietary foam-based technology platform
Worldwide: over 110 granted patents; US: 39 granted patents
Innovative technology & extensive IP
Minocycline Foam
FMX101 for moderate-to-severe Acne
FMX103 for Rosacea
FMX102 for Impetigo
Doxycycline Foam
FDX104 for Chemotherapy-Induced Rash
Portfolio of clinical stage topical foam product candidates
Rehovot Israel & Bridgewater NJ
Strong dermatology track record
Integrated multinational management team
 
 

 
Financial Milestones
 IPO, September 2014
  Net proceeds: US 42.3 million
  Pricing: $6.0 per share
 Cash Position - Q1 2015
  As of March 31, 2015: $48.4 million
 Follow-on offering, April 2015
  Gross proceeds: US$ 69.0 million
  Net proceeds: ~ US$ 64.2 million (net of commissions and expenses)
  Pricing: $9.30 per share
4
 
 

 
Experienced Management Team
5
Name
Experience
 
Headquarters
Dov Tamarkin, PhD
CEO & Director
 Led multiple product developments in dermatology
 Led R&D operations in Israel, EU and US
 
Israel
Meir Eini
Chairman & CIO
 Founder of multiple healthcare ventures
 
Israel
David Domzalski
President, US
 Acted as head of commercial at Warner Chilcott and
 LEO
 Led commercial launch of Doryx® and Taclonex®
 
US
Ilan Hadar
CFO
 Held former finance roles at Israeli subsidiary of
 Pfizer, HP and BAE Systems
 
Israel
David Schuz
EVP, IP
 Led IP operations at BTG Israel and Savient
 
Israel
Mitchell Shirvan, PhD
SVP, R&D
 Former head of R&D, CNS division at Teva
 Former CEO of MacroCure
 
Israel
Alvin Howard
VP, U.S. Regulatory
Affairs
 Acted as head of regulatory affairs at Warner Chilcott
 Led approvals of 14 NDA and sNDAs
 
US
Herman Ellman, MD
VP, U.S. Clinical
Development
 Acted as head of clinical development at Warner
 Chilcott
 
US
Portman
Pharmaceuticals
Clilco
Flexiprobe
 
 

 
Differentiated Foam Technology with
Multiple Platforms
 Patented: over 110 granted patents worldwide(1)
     ◦ 39 granted US Patents(1)
 Capability to formulate multiple drugs
 Suitable for a variety of target sites
 Preferred dermatological alternative to oral delivery
6
Cream Foams
(Emulsion or Emollient)
Ointment Foams
(Petrolatum-based)
Waterless Hydrophilic
Foams (Enhanced penetration)
Oil Foams
Hydroethanolic Foams
Saccharide Foams
(For wounds and burns)
Potent Solvent Foams
(High solubility and delivery)
Suspension Foams
(Concentrated suspensions)
Nano-Emulsion Foams
(Enhanced penetration)
(1) As of March 31, 2015.
 
 

 
Foamix Foams vs. Hydroethanolic Foams
7
 Hydroethanolic foams are
 unstable when heated
  Most foams contain alcohol and
 readily collapse upon exposure to
 skin temperature, hindering
 usability
 Foamix foams are thermally
 stable
  Does not readily collapse upon
 exposure to skin temperature,
 allowing easier application and
 spreading
Foamix
Foam
Hydroethanolic
Foam
 
 

 
Collaborations with Third Parties
 Development and licensing agreements with pharmaceutical companies
 Each license agreement is product specific (Licensee’s drug)
 Licensed products are currently in preclinical, Phase II, Phase III and pre-approval stages
 We retain the rights to develop products for the same indications using our foam
 technology in conjunction with other drugs
 We own the intellectual property for the drug delivery platform
8
 Upfront payments, contingent payments and royalties on sales of products that are
 commercialized
 ~$18 million revenue received as of December 31, 2014
 
 

 
Pipeline of Late-Stage Product Candidates
9
 Pipeline also includes early-stage stable foam formulations with various drugs for the
 treatment of common dermatological indications (e.g., anti-bacterials, anti-fungals and
 corticosteroids)
Product Candidate
Phase I
Phase II
Phase III
Regulatory Pathway /
Target Milestone
Minocycline Foam Candidates
FMX101 for Acne
   
 
 505(b)(2) / Commence Phase III - early 2016
 Phase III data expected 2017
 NDA filing 2017
FMX102 for Impetigo
   
 
 505(b)(2) / Commence Phase III pending FDA
 discussions
FMX103 for Rosacea
 
 
 
 505(b)(2) / Commence Phase II in 2015
 Phase II data 2016
Doxycycline Foam Candidate
FDX104 for Chemotherapy-
Induced Rash
   
 
 Phase II underway
 Phase II data expected 2015
 
 

 
FMX101
Topical Minocycline Foam
For Moderate-to-Severe Acne
10
 
 

 
FMX101: For Moderate-to-Severe Acne
 We successfully stabilized minocycline in a novel topical foam formulation
 Foam delivers minocycline directly to the pilosebaceous unit
11
 Ex-vivo study showed: Minocycline penetrates into the
 pilosebaceous unit
Targeted Delivery to the Pilosebaceous Unit(2)
Sebum
composition
Sebum composition
+
FMX101 Vehicle
FMX101’s Unique Vehicle Dissolves Sebum Composition(1)
(1) Laboratory study, data on file - Foamix Pharmaceuticals Ltd.  (2) Study performed at Charité Universitätsmedizin Berlin.
 
 

 
FMX101: Phase II Clinical Trial - Study Design
 Self-apply to the same region, once daily, in the evening for 12 weeks
 At least 20 inflammatory and 25 non-inflammatory lesions
 Endpoints
  Change in acne lesions
  Investigator’s Global Assessment (IGA)
  Safety and tolerability
12
12-week, randomized, double-blind, dose range-finding study in
subjects with moderate-to-severe acne
Week 12
(End of treatment)
Week 16
(Follow-up)
Week 3
Week 6
Week 9
Randomized (1:1:1), double-blind
N=150
  Minocycline foam 1%(1)
  Minocycline foam 4%(1)
  Foam vehicle(1)
(1) Data on file - Foamix Pharmaceuticals Ltd. Study FX2010-03 CSR.
 
 

 
FMX101: Phase II Clinical Trial Results
13
% Reduction of Non-Inflammatory Lesions
% Reduction of Inflammatory Lesions
* p ≤ 0.05
* * p ≤ 0.01
Foam Vehicle
Minocycline 1%
Minocycline 4%
Dose-dependent reduction of inflammatory and non-inflammatory acne
*
*
Follow
Up
Follow
Up
(1)
(1)
(1) Represents end of treatment.
 
 

 
FMX101: Comparison
Oral minocycline and topical anti-acne drugs for moderate-
to-severe acne
14
Literature Comparison (12 Weeks of Treatment)
(1) Source: Prescription Instruction leaflets of Solodyn, Epiduo and Aczone (average of studies reported for each drug), (2) Head-to-head trials with
 FMX101 were not conducted.
 
4% Minocycline Foam
Solodyn(1)(2)
(oral minocycline)
Epiduo(1)(2)
(Adapalene +
BPO Gel)
Aczone(1)(2)
(Dapsone Cream)
 % Reduction of
 inflammatory lesions
72%
44%
47%
47%
 % Reduction of non-
 inflammatory lesions
73%
No effect
50%
31%
 
 

 
FMX101: Effects on Moderate-to-Severe
Acne Patients
15
FMX101 Phase II Clinical Trial: Patient with moderate-to-severe acne
who responded positively to our treatment (Minocycline Foam 4%)
 
 

 
FMX101: Effects on Moderate-to-Severe
Acne Patients (cont’d)
16
FMX101 Phase II Clinical Trial: Patients with moderate-to-severe acne
who responded positively to our treatment (Minocycline Foam 4%)
12 Weeks
12 Weeks
Baseline
 
 

 
FMX101 - Commercial Overview
17
 
 

 
Moderate-to-Severe Acne: Unmet Medical Need
Moderate-to-severe acne prevalence ~10 million people in the US
18
Mild Acne
Mild Acne
Less than 30 lesions
Less than 30 lesions
<15 Inflammatory lesions
<15 Inflammatory lesions
Moderate Acne
<50 Inflammatory lesions
Moderate Acne
<50 Inflammatory lesions
Severe
Severe
Acne
Acne
>50 Inflammatory lesions
>50 Inflammatory lesions
Topical
 Target market for
 minocycline foam
 (FMX101)
Oral antibiotics
Total US acne prevalence = 40-50 million people per year
 
 

 
19
Source: Symphony Health Analytics DCL (Dynamic Claims Lifecycle).
Form
US Dollars
Topical
$1.3 billion
Oral
$1.7 billion
Total
$3.0 billion
 
 

 
A Competitive Landscape with No Dominant Leader
Top brands oral and topical formulations (LTM January 2015)
20
Source: Symphony Health Analytics DCL (Dynamic Claims Lifecycle).
(1) Indicated for the treatment of Rosacea, (2) The charts show the respective market shares of the oral branded prescription acne drug market and
the topical branded prescription acne drug market according to the total number of prescriptions.
 
Top Oral Brands
US Dollars
1
ORACEA (1)
$399,553,613
2
SOLODYN
378,680,981
3
DORYX
236,947,892
4
MONODOX
180,363,148
5
ACTICLATE
103,068,443
 
Top Topical Brands
US Dollars
1
EPIDUO
$392,925,581
2
ACZONE
357,780,787
3
FINACEA (1)
149,158,927
4
ACANYA
139,396,592
5
ZIANA
124,444,412
(1
)
(1
)
 
 

 

A Pro-Commercial Reimbursement Environment
Payer mix: branded acne drugs (all payer types / LTM January 2015)
21
Source: Symphony Health Analytics DCL (Dynamic Claims Lifecycle).
(1) Assistance Programs include aid for “medically indigent” patients (those who are without insurance, have low income or are ineligible for public
programs) which can be privately or State funded and coupon programs that have been identified and profiled.
Commercial Payers and Cash account for 71% of total
reimbursement within the Oral Branded Market.
Oral
Commercial Payers and Cash account for 78% of total
reimbursement within the Topical Branded Market.
Topical
(1)
(1)
 
 

 

Prescription (Rx) Volume Driven by Small
Prescriber Base
Attractive and efficient for commercialization
22
Source: Symphony Health Analytics DCL (Dynamic Claims Lifecycle). Data from April 2012 - March 2014.
Total Active Derms
(13,971)
Rx Volume
(80%)
Rx Volume
(100%)
 ~33% of dermatologists
 generate ~80% of Rx
 volume
 Foamix intends to utilize
 a small, dedicated sales
 force deployment to
 optimize coverage
   50-75 reps
Target Universe
Derms
(4,538)
 
 

 
FMX103
Topical Minocycline Foam
For Rosacea
23
 
 

 
FMX103: Rosacea
 FMX103 is a minocycline foam in development for the treatment of
 rosacea
 Rosacea lesions and inflammatory acne lesions have a number of
 dermatological similarities
 Approximately 16 million people are afflicted
  ◦ ~$1.2 Billion market(1)
  ◦ Current treatment options include topicals such as azaleic acid
       (Finacea®) and metronidazole (Metrogel®), as well as oral
       minocycline or oral doxycycline (Oracea®)
 Commence Phase II trial (2015)
24
(1) Symphony Health Analytics DCL (Dynamic Claims Lifecycle).
 
 

 
Planned: 210 subjects
12 weeks’ treatment duration
Efficacy evaluation
and safety
assessments
performed at weeks
1, 2, 4, 6, 8, 10, and
12
FMX103
(high dose)
~70 subjects
FMX103
(low dose)
~70 subjects
Foam vehicle
(placebo)
~70 subjects
Randomized (1:1:1)
Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study
 Facial Rosacea
Safety Assessments
 Standard safety measures
 Other rosacea signs and symptoms
Primary Efficacy Assessments
 Inflammatory lesion count
 IGA scores
Clinical Study Protocol - Foamix Ltd. Study FX2014-06.
FMX103: Phase II Study Design
25
 
 

 
26
(1) The chart below shows the approximate market shares of the branded prescription rosacea drug market according to total number of
prescriptions.
Total Market: ~$1.2 billion
     
1
ORACEA (oral doxycycline)
$297,941,611
2
METRONIDAZOLE
$270,704,800
3
FINACEA
$125,135,634
4
MIRVASO
$49,014,674
5
DOXYCYCLINE
$37,816,825
 
 

 
FMX102
Topical Minocycline Foam
For Impetigo, Including MRSA
27
 
 

 
FMX102: Impetigo
 FMX102 is a low dose formulation of minocylcine foam in development for the treatment
 of impetigo, including MRSA infections
 Impetigo is a highly contagious bacterial skin infection, primarily affecting preschool-aged
 children
 US market size approximately $330 million
  Majority of market attributed to Bactroban and other mupirocin-based topical products
 Phase II trial completed in 2012
  Design: randomized, double-blind study, without a control group, of 32 pediatric
 patients with at least 2 impetigo lesions (11 had MRSA infection)
  Treatment: 1% or 4% minocycline foam was applied topically twice-daily for 7 days,
 with an additional follow-up at 14 days
  End Points: absence or improvement(1) of treated lesions and dried lesions without
 crusts, with/without erythema
28
(1) Data on file - Foamix Pharmaceuticals Ltd. Study FX2010-01; draft CSR.
 
 

 
FMX102: Phase II Trial Results
 Current benchmark BACTROBAN® (mupirocin) achieves 71%-96% of clinical efficacy within
 8-12 days of treatment
29
D. Foam: A unique delivery vehicle for topically applied formulations. In: Dayan N. Apply Topically: A Practical
81.3%
92.3%
100%
Day 3
Day 7 (end of treatment)
Day 14 (follow-up)
(1) 1% and 4% Minocycline were equally effective after Day 14 and substantially similar after Days 3 and 7. Data on file - Foamix Pharmaceuticals
Ltd. Study FX2010-01; draft CSR.
Efficacy
 
 
 

 
FMX102: Phase II Trial Results
Visible improvement / lesion clearance with treatment(1)
30
Baseline
Day 3
Day 7 (End of treatment)
Patient A
Patient B
Patient C
(1) Patients A, B and C received minocycline foam 1%.
 
 
 

 
FDX104
Topical Doxycycline Foam
For Treatment of Chemotherapy-Induced Rashes
31
 
 

 
FDX104: For Chemotherapy-Induced Rash
 Background
  Patients taking Erbitux (and other EGFRI drugs) are affected by
 severe acne-like rashes
  Between 45% to 100% of EGFRI patients develop severe acne-
 like rashes
  32% discontinue therapy
  No approved treatments for chemotherapy-induced rashes
  Oral doxycycline and minocycline are used ‘off-label’
  Limitations
  Systemic side effects
  Potential drug-drug interaction with EGFRI drugs
 Product: Doxycycline Foam 4%
 Phase II trial commenced Q4, 2014
  Target Enrollment: 24 patients
  Expected top line results - 2015
32
 
 

 
Highlights
33
Including Bayer, Actavis and Merz
Collaborations with leading pharma companies
Proprietary foam-based technology platform
Worldwide: over 110 granted patents; US: 39 granted patents
Innovative technology & extensive IP
Minocycline Foam
FMX101 for moderate-to-severe Acne
FMX103 for Rosacea
FMX102 for Impetigo
Doxycycline Foam
FDX104 for Chemotherapy-Induced Rash
Portfolio of clinical stage topical foam product candidates
Rehovot Israel & Bridgewater NJ
Strong dermatology track record
Integrated multinational management team
 
 

 
May 2015