immy_8k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  July 23, 2013

IMPRIMIS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware
 
001-35814
 
45-0567010
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)

12626 High Bluff Dr. Ste 150
   
San Diego, CA
  92130
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (858) 704-4040

N/A
(Former name or former address if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
o
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
o
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
o
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



 
 
 
 

Item 7.01. Regulation FD Disclosure
 
Attached as Exhibit 99.1 to this Item 7.01 is a presentation that is being used by the management of Imprimis Pharmaceuticals, Inc. (the “Company") in meetings describing the Company.
 
The information contained in Item 7.01 of this report and in Exhibit 99.1 shall not be deemed “filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
 
Item 9.01.  Financial Statements and Exhibits
 
(d)           Exhibits
 
Presentation dated July 2013
 
 
2

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
IMPRIMIS PHARMACEUTICALS, INC.
 
       
Dated: July 23, 2013 
By:
/s/ Andrew R. Boll  
    Name: Andrew R. Boll   
    Title: Vice President, Accounting and Public Reporting   
       
 
 
3

 
 
EXHIBIT INDEX
 
Presentation dated July 2013
 

 
 
 
4

immy_ex991.htm
Exhibit 99.1
 
Imprimis Pharmaceuticals, Inc.
“A Unique Approach to 505(b)(2)”
July 2013
Mark L. Baum, C.E.O.
 
1

 
Safe Harbor Statement
This presentation contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act
of 1995. You are cautioned not to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from our expectations and projections.
Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include
the difficulties related to the Company’s ability to obtain regulatory approval to market Impracor™, capitalize on
its perceived potential benefits arising from its relationship with Professional Compounding Centers of America,
Inc., leverage compounded generic drugs to create a development pipeline and otherwise pursue its business
plan, and leverage its Accudel technology in the development of potential product candidates. In addition, the
outcome of the final analyses of the data from the past and future Phase 3 clinical trial may vary from the
Company’s initial conclusions, the FDA may not agree with the Company’s interpretation of such results or may
challenge the adequacy of the Company’s future Impracor clinical trial design or the execution of the same clinical
trials, the FDA may require the Company to complete additional clinical trials for Impracor before the Company
can submit a 505(b)(2) NDA application, the results of any future clinical trials may not be favorable and the
Company may never receive regulatory approval for Impracor™, the Company may be unable to raise additional
funding to complete its product development plans, or be unable to acquire, develop or commercialize new
products and or enter into strategic alliances and transactions. Other risks include uncertainties inherent in pre-
clinical studies and clinical trials, difficulties in conducting its clinical trials, unexpected new data, safety and
technical issues, competition and market conditions. More detailed information about the Company and the risk
factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the
Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC’s web site at
www.sec.gov.
 
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the
date hereof, given these risks and uncertainties. All forward-looking statements are qualified in their entirety by
this cautionary statement and the Company undertakes no obligation to revise or update any forward-looking
statements as a result of new information or future events or developments.
 © Imprimis Pharmaceuticals, Inc. | *
 
2

 
Imprimis Overview
 © Imprimis Pharmaceuticals, Inc. | *
 
3

 
Imprimis Snapshot
 © Imprimis Pharmaceuticals, Inc. | *
 Approx. $19.0M in cash as of 03/31/13
 Nominal debt; no preferred instruments
 Phase 3 topical NSAID pivotal to start in Q3 2013
 Exclusive commercial rights to PCCA development IP
  10,000+ drug formulations
  10+ drug delivery technologies
  Vast market “unmet need” database
 Exclusive access to review PCCA member IP
 Experienced science and management teams
 
4

 
Imprimis Overview
 © Imprimis Pharmaceuticals, Inc. | *
Low Risk
Low Margin
505(b)(2) … Lower Risk | Higher Margin
Our mission is to develop proprietary drugs using the
FDA 505(b)(2) drug development pathway
 
5

 
Less Development Time & Lower Cost
Application
505(b)(1) NDA
505(b)(2) NDA
505(j) ANDA
 
New Chemical Entity
(NCE)
Yes
Yes/No
(Rely on RLD and Prior Investigation)
No
(RLD is off patent)
New Indication
Yes
Yes
No
New Form/Dose
Yes
Yes
No
Required Data for
Approval
 Complete Pharmacology
 Complete Preclinical
 Safety, including long
 term carcinogenicity in 2
 species
 Complete analytical
 development and quality
 manufacturing
 Complete Phase 1-3
 clinical trials
 Data from published literature
 FDA findings on efficacy/safety of
 approved drug/formulation
 Studies to support change
  Dermal/Eye Safety (topical drugs)
  Clinical Efficacy/Safety
  CMC (3 registration batches with
 stability data)
 Bioequivalence
 505(b)(2) products can have Orange Book-listed patents, can enjoy 30-month protection against
 generic competitors; NCE (5 yrs); Orphan Drug (7 yrs); Pediatric Extension (6 mos.)
 
 505(b)(2) Development Budget Comparison: $2-7M versus $100M+ for (b)(1)
 © Imprimis Pharmaceuticals, Inc. | 6
 
6

 
Imprimis Development Model
 © Imprimis Pharmaceuticals, Inc. | *
Imprimis Brings Innovation
from Pharmaceutical Compounders
to the >$300B U.S. Pharmaceutical Industry
Pharmaceutical
Compounders
1%
99%
 
7

 
PCCA Strategic Relationship
 Professional Compounding Centers of America
 (PCCA) is the largest compounding pharmacy
 organization in North America
1. Supply chemicals, equipment, accredited training, software,
 and business/pharmacy consulting assistance
 Over 4,000 pharmacy businesses/chains worldwide
 PCCA relationship gives Imprimis exclusive access to:
 1. Proprietary and proven drug formulations
 2. Proprietary and proven drug delivery technologies
 (Lipoderm® and others)
 3. Market data (>100,000 inbound calls per year)
 4. Analytics (Eagle Analytics)
 5. Exclusive access to review PCCA member IP
 Our strategic relationship is exclusive
 PCCA invested $4M into Imprimis at $4.80 per share
505(b)(2) Focused
Proprietary Drug Pipeline
+
 © Imprimis Pharmaceuticals, Inc. | *
 
8

 
Imprimis Vision
 © Imprimis Pharmaceuticals, Inc. | *
 Drive Shareholder Value
Monetize vast 505(b)(2)
development assets
  Selectively internal
 development 
  Partner
  Out-license
 Improve Patient Care
Novel drug administration
  Reduce or eliminate
 negative side effect
 profiles
  Increase therapeutic
 benefit to patients
 
9

 
Monetizing the PCCA Relationship
Step 1: Opportunity Matrix
  X-Axis: Drug Administration
  Competition
  Reimbursement Landscape
  Dollar Size
  Number of Annual RX
Internally Develop
Partner, Out-License
 
10

 
Imprimis Growth & Development Process
Ideas
Candidates
Projects
 Market Data
 Drug Master File
 Field Experience
 Out-License or Develop
 Complete Phase 3
 NDA via 505(b)(2)
 Market Launch/Partner
NDA & LAUNCH
Candidate
 
11

 
Imprimis Pipeline
 © Imprimis Pharmaceuticals, Inc. | *
 
12

 
Imprimis Pipeline
Therapeutic
Area
Compound
Indication
Market Analysis
 
PAIN
 
IPI110
Impracor™, Ketoprofen 10%
Cream
Sprains, Strains and
Joint Pain
$10B US NSAID Market
Transitioning to Topicals due to high incidence of AEs
 
Voltaren Gel has 75% Rx Share
 
Topical NSAID market may
exceed $1B by 2015
 


OPHTHALMOLOGY
IPI004**
Corticosteroid +
Antibiotic
Prophylaxis of Post-
Operative Complication
following Cataract,
Glaucoma, and Retinal
Surgery
19M Global Cataract Surgeries (2011); $200-
$300/drugs/US surgery
 
Growing Market due to Aging Pop. and Demand to have
surgery at an earlier age
 
Combination (single injection) will minimize risk for injury
and infection versus multiple injections
 
WOUND HEALING
IPI120
Tranexamic Acid + Antibiotic
Topical wound care
treatment of genetic
and acquired bleeding
disorders
$9B Global Bleeding and Clotting Disorders Market
 
$17B US Wound Care Market
 
7M American suffering from chronic wound, annually

**
Imprimis has an exclusive option and right to negotiate to acquire this drug formulation and intellectual property based on substantially prenegotiated terms.
 © Imprimis Pharmaceuticals, Inc. | *
Additional compounds in late stage assessment are in the therapeutic areas of
Pain and Sexual Dysfunction
 
13

 
Improving Patient Care:
Impracor
Phase 3
Topical NSAID
 © Imprimis Pharmaceuticals, Inc. | *
 
14

 
The Topical NSAID Market
 © Imprimis Pharmaceuticals, Inc. | 15
 
15

 
The Case for Impracor
 © Imprimis Pharmaceuticals, Inc. | *
  Market Analysis:
  The $10B+ US NSAID Market is Transitioning to Topicals
  Voltaren Gel (1% diclofenac) has ~75% Rx share
  FDA Guidance: Voltaren™ generics must complete clinical trials prior to ANDA
  Despite Suboptimal Products, U.S. Topical NSAID Market is Growing
  2016 Topical NSAID Market Possibly >$1B
  There is a compelling unmet need for an effective semi-solid NSAID
Factor
Impracor™
Voltaren®
Delivery Technology
Patented Accudel™ Micelles
None; Alcohol
API
10% Ketoprofen
1% Diclofenac
COX Selectivity
Cox 1
Cox 2
Smell
Neutral
Insect Repellant
Tactile
Smooth
Greasy
 
16

 
Impracor Phase 3 Program
Initial Phase 3 Trial
 mITT analysis: p=0.038
 Per protocol analysis: p=0.034
New Acute Pain Clinical Trials to Achieve FDA Approval
 Two adequate/well controlled acute pain trials (one in label)
 Leading pain trial experts have designed protocol
 Use proprietary tools to reduce placebo effect
 Seek “sprains, strains and joint pain” label
 Could be the only acute pain topical NSAID (if FDA approved)
 OA Flare trial protocol IRB Approved
 © Imprimis Pharmaceuticals, Inc. | *
Phase 3 Clinical Trials Planned - Q3 2013
Trial Data - 1H 2014
 
17

 
Executive Team and
Select Financial Data
 © Imprimis Pharmaceuticals, Inc. | *
 
18

 
Management Team Snapshot
Strong operational and management experience within our leadership group
Compensation weighted in equity
Chief Executive Officer: Mark L. Baum, J.D.  
15+ Years of Senior Executive Experience; Founder/President, YesRx.com (1999)
Founder of 3 private investment funds; Restructured numerous companies (private-to-public)
Responsible for Restructuring Imprimis, including ~$24M new equity investment and PCCA transaction
Senior Advisor, Pre-Clinical Services: Balbir Brar, D.V.M., Ph.D.
25 Years of Senior Drug Development Experience
Senior Positions: Lederle/Wyeth, SmithKline & Beckman, and Allergan
Drugs: Botox, Ketorolac (Cataracts), Restasis (Dry Eye), Lumigam, Latisse, Alphagan and 8 other drugs
Chief Medical Officer: Joachim P.H. Schupp, M.D.
Senior Positions: Ciba-Geigy, Novartis, ProSanos, Adventrx, Apricus Biosciences
Drugs: Voltaren line extensions, Apligraf, Femara, Exjade and Sandoglobulin
VP, Accounting and Public Reporting: Andrew R. Boll
8+ years of experience in small capitalization company financial reporting; focus on restructured businesses;
Led forensic-type accounting and financial reporting of historical Imprimis records during restructuring
VP, Corporate Development: Gary Seelhorst, MS, MBA
15+ years of clinical and corporate development experience with both large-cap pharmaceutical companies
(e.g. Eli Lilly and Pfizer) as well as start-up ventures including extensive capital raising, licensing, and M&A
transactions
 © Imprimis Pharmaceuticals, Inc. | *
 
19

 
Clinical and Regulatory Team Snapshot
Senior Regulatory Advisor: Lee S. Simon, M.D.
FDA Division Director of Analgesic, Anti-Inflammatory & Ophthalmologic Drug Products (2001-2003)
Served on multiple FDA advisory committees; 12 years as an NIH funded investigator
Senior consultant to Pharmacia/Searle on COX-2 development
Two terms on the BOD of the American College of Rheumatology; 110 Original Publications
Senior Clinical Advisor: Roy D. Altman, M.D.
Professor of Medicine, Division of Rheumatology/Immunology at UCLA ; 35+ yrs clinical experience
Founding Member/Past President of the Osteoarthritis Research Society International
Chairman for the Design and Conduct of Clinical Trials in Osteoarthritis as well as the Chairman on
Clinical Trials in Osteoarthritis; Over 200 juried manuscripts and over 60 books
Edited the 4th edition of Osteoarthritis: Diagnosis and Management.
Co-editor:Seminars in Arthritis and Rheumatism and Editor and Chief of Osteoarthritis and Cartilage
Senior Clinical Advisor: Marc C. Hochberg, M.D.
Faculty, The Johns Hopkins University SOM & University of Maryland SOM
Head of the Division of Rheumatology and Clinical Immunology at University of Maryland SOM
Focus on clinical epidemiology of musculoskeletal diseases, osteoarthritis and osteoporosis
PI of NIH and Dep’t Vet. Affairs funded studies, and is a Co-investigator on several other studies
Senior Regulatory Advisor: Allan M. Green, M.D., PhD, J.D.  
Physician, Attorney, Inventor and Research Scientist
Operating and Management Experience with Numerous Biomedical Companies
Of Counsel to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Teaches Food and Drug Law at Boston College Law School
 © Imprimis Pharmaceuticals, Inc. | *
 
20

 
Capital Structure
 
Capital Structure
March 31, 2013
(Unaudited)
Percent
Common Shares
8,888,250
82.72%
Total Restricted Stock Units
200,000
1.86%
Total Options & Warrants - Weighted Avg. Ex. Price
$5.42
1,656,258
15.42%
Total Common Shares - Diluted
10,744,508
100.00%
 
 
 
 © Imprimis Pharmaceuticals, Inc. | *
 
21

 
Summary
 © Imprimis Pharmaceuticals, Inc. | *
 Imprimis is a Company with Vision
 Unique Drug Development Model
 Near Term Catalysts
 Robust and Compelling Development Assets
 Key Strategic Relationships
 Cash Resources to Execute
 Highly Capable Team
 
22

 
Questions & Discussion
Imprimis Pharmaceuticals, Inc.
Delivering Safe, Effective and Direct Solutions
FOR MORE INFORMATION CONTACT:
Mark L. Baum, J.D.
(858) 433-2816 - Direct
mark@imprimispharma.com
 © Imprimis Pharmaceuticals, Inc. | *
 
23

 
Appendix - Investment
Summary & Support
 © Imprimis Pharmaceuticals, Inc. | A1
 
24

 
Accudel Topical
Delivery Technology
 © Imprimis Pharmaceuticals, Inc. | A2
 
25

 
Introduction to Accudel
Pluronic Lecithin Organogel (PLO) Platform
Lipophillic APIs
Hydrophillic APIs
Pluronic Phase
Lecithin Phase
 Accudel™ is a cream that “carries” drugs
 through the skin,
penetrating to the problem site
 Pluronic Lecithin Organogel (PLO) drug carrier
 Accommodates different size molecules and large
 quantities of active drugs
 Works with drugs with different physicochemical
 properties
 Quickly absorbed and aesthetically pleasing
 Low toxicity and biodegradable; components are
 non-immunogenic and are “Generally Regarded
 As Safe” (GRAS) by the US FDA
 Thermodynamically stable, insensitive to moisture
 and resistant to microbial contamination
Drug
 © Imprimis Pharmaceuticals, Inc. | A3
Lecithin Phase
Drug
Pluronic Phase
 
26

 
Introduction to Accudel
In Vitro Penetration Data for Impracor and
 European Marketed Products (Fastum
®, Ketum®, Oruvail®)
 63% - 70% of ketoprofen in Impracor that was available for
 release diffused through the membrane (0.45
m Nylon) of a
 Franz Cell Apparatus within 4 hoursi.
 (Fastum, Ketum, Oruvail) 2.5% topical ketoprofen were tested
 in a Franz Cell Apparatus (Silicon membrane). Less than
20%
 of ketoprofen
present in the formulation was made available to
 diffuse out of the formulation into the receptor phase in the un-
 ionized formii.
i. DPT Study Report TC.0706.01
ii. Thesis Tettey-Amlalo, Dec 2005
Faculty of Pharmacy Rhodes University, Grahamstown
 © Imprimis Pharmaceuticals, Inc. | A4
 
27

 
Impracor Topical
NSAID
Competition and Market
 © Imprimis Pharmaceuticals, Inc. | A5
 
28

 
The Problem With Oral NSAIDs
 Solution is to deliver NSAIDs topically to the specific site of pain or inflammation
Fact: Extremely Large Population Uses NSAIDs
70 Million prescriptions for NSAIDs each year in US (Wiegard in Medscape)
Regularly used by more than 60M Americans (Arch Intern Med. 2005;165:171-177)
70% of all 65+ Year Olds Take NSAIDs Weekly
Usage of oral NSAIDs is increasing
Result: Toxicity to Gastro Intestinal (GI) Tract, Kidneys and Liver
Over 100,000 per year are hospitalized from NSAID complications
Hospitalizations alone cost more than $2B per year
Over 16,000 deaths every year from GI NSAID complications
NSAID GI Toxicity - the 15th most common cause of death in US
Widespread Usage With Serious Side Effects
 © Imprimis Pharmaceuticals, Inc. | A6
 
29

 
Competitive Landscape
10% Ketoprofen
Cream
Proprietary
Safe / Cutaneous
Elegant Formulation
Convenient / Cream
Accudel Delivery System
Local AEs 1-2%
Seeking label sprains,
strains, and joint pain
IMPRACOR
(Imprimis)
1.3% Diclofenac
epolamine
10 x 14 cm patch
2 x per day
Fixed one size patch
Adherence issues
Not to be worn in water
Local AEs 11%
Acute soft tissue
injury (positive data
in ankle sprain)
FLECTOR PATCH
(Pfizer/IBSA)
1% Diclofenac
sodium
2-4 gram
4 x per day =
16 grams/day
Large Quantities
Sticky / Greasy
Odor / Staining
Local AEs 7%
Chronic OA of hand
and knee
VOLTAREN GEL
(Endo/Novartis)
1.5% Diclofenac
sodium
40 drops of liquid
(10 drops to each of 4 sides of knee)
3-4 x per day =
160 drops/day
Dimethyl sulfoxide
(DMSO); Safety concerns
Complicated application
Causes garlic taste/breath
Local AEs 47%
Chronic OA of knee
PENNSAID
(Covidien/Nuvo)
 © Imprimis Pharmaceuticals, Inc. | A7
 
30

 
Ketoprofen vs. Ibuprofen
“Meta-analysis of 26 trials (n=2,853) … showed that Ketoprofen was
significantly better than all other topical NSAIDs. In terms of efficacy,
Ketoprofen was significantly better than ibuprofen, felbinac, piroxicam and
indomethacin.”
Topical NSAIDs for acute pain: a meta-analysis
Lorna MasonR Andrew Moore*Jayne E EdwardsSheena Derry and Henry J McQuay
BMC Family Practice 2004, 5:10
 
The Impracor Solution
 Ketoprofen vs. Diclofenac
 The proportion of participants experiencing successful treatment with topical
ketoprofen in seven clinical studies was 73%
(251/346, range 57% to 89%)
 The proportion of participants experiencing successful treatment with topical
diclofenac in three clinical studies was 52%
(166/319, range 39% to 92%)
Ketoprofen is a Superior Active Ingredient
 © Imprimis Pharmaceuticals, Inc. | A8
Topical NSAIDs for acute pain in adults.
Massey T, Derry S, Moore RA, McQuay HJ
Cochrane Database Syst Rev. 2010;6:CD007402
 
31

 
Additional Impracor
Clinical Materials
 © Imprimis Pharmaceuticals, Inc. | A9
 
32

 
Topical NSAIDs in Acute OA Knee Pain Model
 © Imprimis Pharmaceuticals, Inc. | A10
 
Ketoprofen 20% Patch
(ENDO)
Ketoprofen Transfersome
Gel, Diractin™ (IDEA)
Diclofenac Solution
Pennsaid™ (Nuvo)
Phase
3
2/3
2
Study Dates
Aug 2006 - May 2007
Jul 2003 - Jan 2004
Jul 2010 - Mar 2011
# of Subjects/ Age
309 / above 18 years
397/ above 40 years
248 / 18 -80 years
Regimen/ Duration
Ketoprofen Patch applied o.d.
4 weeks
 
110 mg ketoprofen b.i.d. (n=138)
6 weeks
(1 placebo capsule b.i.d.
100 mg celecoxib capsule b.i.d.)
 
1.3 mL applied to front, back and sides of knee
b.i.d. (n=84)
Vehicle and placebo controlled
4 weeks
Selection
Diagnosis of knee (unilateral or bilateral),
CRO: PPD
 
Morning stiffness < 30’, crepitus, at least 3 on
Likert’s 5 point scale, not on NSAIDS
 
Patients using NSAIDs underwent a 1-week
washout
This was a non-flare study
 
Primary Endpoint
 
WOMAC (pain) week 2
WOMAC (pain ) week 6•
WOMAC (pain ) week 4
Secondary Endpoints
Pain Intensity/ relief (diary)
WOMAC (function), Rescue Medication,
quality of sleep, lost days of work. Pat./Phys.
global assessment
WOMAC (function)-week 6.
Patient global assessment
(5 Point Likert)•
WOMAC (stiffness) , WOMAC (function), WOMAC
(pain on walking) - - week 4
Patient global assessment
Pain assessment 11 point scale
Conclusions
ITT Primary Endpoint met: Significant
differences vs placebo (p=0.014). All
secondary endpoints met. Previously
two
Phase 3 sprain/strain trials failed,
program discontinued.
ENDO 10Q 2007
WOMAC pain LS mean reduction - 18.2 (-22.1 to -
14.3), -20.3 (-24.3 to -16.2) and -9.9 (-13.9 to -
5.8) osteoarthritis (p <0.01)
All WOMAC subscale scores were normalized to
a scale of 0 to 100 by dividing the sum subscale
score by the number of questions of each score
.
Ann Rheum Dis. 2007; 66(9): 1178-83.
Swissmedic approval based on single study
WOMAC pain reduction (5-Point Likert) from
baseline (-3.9 [- 4.8 to -2.9]) compared with vehicle
-control solution (-2.5 [- 3.3 to -1.7]; p = 0.023) or
the placebo solution (-2.5 [-3.3 to -1.7]; p = 0.016).
CMAJ • AUG. 17, 2004; 171 (4)
5 Phase 3 trials have achieved all 3 primary end
points in OA.
 
33

 
Initial Phase 3 Trial
Design:
Randomized, double-blind, placebo-controlled at 26 sites
Study Population:
Efficacy, n = 361
Uncomplicated acute soft tissue injuries
Ankle (n=97), Shoulder (n=87), Knee (n=59), Wrist (n=57), Elbow (n=30), Calf/Anterior Tibialis
(n=11), Hamstring/Quadriceps (n=8), Forearm (n=5), Biceps/Triceps (n=3), Hand (n=3)
 
Safety, n = 364
Ranging in age from 18 - 75 years
Key Entry Criteria:
Injury occurred within 72 hours, pain intensity ≥ 60mm on 100 mm Visual Analogue Scale
(VAS); no intake of unallowable medication
Dosing Regimen:
Impracor vs. Placebo (Vehicle) cream, 1g t.i.d. x 7 days
Primary Endpoint:
Change from baseline in pain intensity during daily activities on Day 3 office
visit (+1, +2 days) with 100 mm VAS measurement
Secondary
Endpoints:
 Change from baseline in three times daily pain intensity immediately prior to medication
 Various other treatment satisfaction and safety assessments
 Pharmacokinetics in subset of patients
Sprain-Strain Soft Tissue Study
 © Imprimis Pharmaceuticals, Inc. | A11
 
34

 
Safety: Low Incidence of Adverse Events
* Clinical Study Report: TDLP-110-001, September 2010  
** Prescribing Information for Flector Patch, Voltaren Gel and Pennsaid Solution
 No related gastrointestinal (GI), cardiac, liver, or other serious AEs
 Low incidence of cutaneous AEs
 © Imprimis Pharmaceuticals, Inc. | A12
1g, 3x daily
180mg, 2x daily
4g, 4x daily
40 drops, 4x daily
**
**
**
**
**
*
*
 
35

 
Pharmacokinetics: Low Systemic
Absorption
* Cannavino, C. et al. Efficacy of Transdermal Ketoprofen in delayed onset muscular soreness,Clinical Journal of Sports Medicine, 13: 200-208,
 2003 and Clinical Study Report Project No. 990808, Phase 1/2 Study Report Aug 2007
**Orudis ketoprofen extended release capsule/ Oruvail capsule prescription information
Impracor*
10% ketoprofen cream
Oruvail**
1g t.i.d. (48hr)
2g t.i.d. (48hr)
 © Imprimis Pharmaceuticals, Inc. | A13
Orudis**
 
36

 
Additional Corporate
Information
 © Imprimis Pharmaceuticals, Inc. | A14
 
37

 
Board of Directors
Robert J. Kammer, D.D.S. (Co-Founder)
Active Clinical Research & Consulting Practice; Diplomate, American Board of Orofacial Pain
Retired Associate Professor & Course Director - Orofacial Pain, University of Colorado
Mark L. Baum, J.D. (Co-Founder)  
15+ Years of Senior Executive Experience
Founder of 3 private investment funds; Restructured numerous companies (private-to-public)
Responsible for Restructuring Imprimis, including $24M New Equity Investment and PCCA transaction
Paul Finnegan, M.D., M.B.A.
Senior Positions: Avalon Ventures, Alexion, Pharmacia/Searle); Univ. of Chicago MBA
Drugs: Celebrex, Bextra, Arthrotec, Soliris, Inspra and Aldactone/Soldactone
Jeff Abrams, M.D.
Director since 1998; Co-developer of Accudel drug delivery technology and Impracor topical NSAID
Stephen Austin, C.P.A.
Audit Committee Chairman; Significant BOD Experience; Partner, Swenson Advisors, LLP since May
1998
Manages audit, SEC, Sarbanes-Oxley and business consulting engagements with a focus on technology,
manufacturing, service, real estate, social media and non-profit organizations
Gus S. Bassani, Pharm.D
Shareholder in PCCA; Vice-President of Consulting, R&D and Formulations at PCCA
Member of the 2010 - 2015 United States Pharmacopeia (USP) Council of Experts
 © Imprimis Pharmaceuticals, Inc. | A15
 
38

 
Balance Sheet
ASSETS
 
March 31, 2013
Current Assets
 
 
 
Cash and short term investments
$
19,029,031
 
Other assets
 
217,540
 
 
TOTAL ASSETS
$
19,246,579
LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
Accounts payable and other accruals
$
848,549
 
 
TOTAL LIABILITIES
 
848,549
Stockholder’s Equity
 
 
 
Common stock, $0.001 par value, 395,000,000 shares authorized,
 
 
 
 
8,888,250 shares issued and outstanding
 
8,888
 
Additional paid-in capital
 
43,958,891
 
Deficit accumulated during the development stage
 
(25,569,749)
 
 
TOTAL STOCKHOLDERS' EQUITY
 
18,398,030
 
 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
19,246,579
 © Imprimis Pharmaceuticals, Inc. | A16
(Unaudited and Abbreviated)
39