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):  April 12, 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.)

 
 
 
437 South Hwy 101, Suite 209
 
92075
Solana Beach, CA
   
(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 April 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: April 12, 2013 
By:
/s/ Mark L. Baum  
   
Name: Mark L. Baum
 
   
Title: Chief Executive Officer
 
       
 
 
 
3

 
EXHIBIT INDEX


 
Presentation dated April 2013
 

4

immy.htm
Exhibit 99.1
 
Imprimis Pharmaceuticals,
Inc.
“Positioned to Monetize One of the Largest
 Databases of Compounded Drug Formulations”
April 2013
Mark L. Baum, C.E.O.
 
1

 
Safe Harbor Statement
The Company cautions you that the statements included in this presentation are not a description of historical
facts and are 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. These include statements regarding the Company’s
interpretation of the results of its Phase 3 clinical trial for Impracor™, the Company’s ability to obtain regulatory
approval to market Impracor™, the Company’s potential benefits arising from the Company’s relationship with
Professional Compounding Centers of America, Inc., the Company’s ability to leverage compounded generic
drugs to create a development pipeline and otherwise pursue its business plan and the Company’s ability to
leverage its Accudel™ technology in the development of potential product candidates.
These forward-looking statements are based on management’s current expectations, estimates, forecasts and
projections about the Company and are subject to risks and uncertainties that could cause actual results and
events to differ materially from those stated in the forward-looking statements. Actual results may differ materially
from those set forth in this presentation due to the risks and uncertainties inherent in the Company’s business,
including, without limitation: 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 continue to 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™; and the
Company’s possible need to raise additional funding to complete its product development plans.
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 this presentation to
reflect events or circumstances after the date hereof.
 © Imprimis Pharmaceuticals, Inc. | *
 
2

 
Imprimis Overview
 © Imprimis Pharmaceuticals, Inc. | *
 
3

 
Imprimis Snapshot
 © Imprimis Pharmaceuticals, Inc. | *
 Approx. $19.5M in cash1
 Nominal debt; no preferred instruments
 Phase 3 topical NSAID pivotal to start mid 2013
 Exclusive commercial rights to PCCA development IP
  10,000+ drug formulations
  10+ drug delivery technologies
  Vast market “unmet need” database
 Accudel™ targeted drug delivery platforms
 Experienced science and management teams
 
1) Cash position at December 31, 2012 ($10M), and net proceeds $(9.5M) of public offering and over-allotment exercise February/March, 2013
 
4

 
Imprimis Overview
 © Imprimis Pharmaceuticals, Inc. | *
Low Risk
Low Margin
505(b)(2) … Lower Risk | Higher Margin
We develop proprietary drug assets using the 505(b)(2) 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 3,900 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
 Our strategic relationship is exclusive
 PCCA invested $4M into Imprimis at $4.80 per share
Risk Mitigated
Proprietary Drug Pipeline
+
 © Imprimis Pharmaceuticals, Inc. | *
 
8

 
Imprimis Vision
 © Imprimis Pharmaceuticals, Inc. | *
 Drive Shareholder Value
Monetize vast PCCA IP 
  and development assets
  Selective 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
  Y Axis: Health Categories
  Competition
  Dollar Size
  Number of Annual RX
Internally Develop
Partner, Out-License
 
10

 
Improving Patient Care:
Impracor
Phase 3
Topical NSAID
 © Imprimis Pharmaceuticals, Inc. | *
 
11

 
The Case for a Topical NSAID
 
Oral NSAIDs
Topical NSAIDs
Efficacy in Acute Soft Tissue Injuries
Good
Good
Efficacy in Osteoarthritis
Good
Good
Incidence of Adverse Events
High
Low
GI Safety (Stomach)
Poor
Good
Hepatic Safety (Liver)
Poor
Good
Renal Safety (Kidney)
Poor
Good
Cardiovascular Safety (Heart)
Poor
Good
 © Imprimis Pharmaceuticals, Inc. | *
Resultant Complications from Systemic (Oral) NSAID Use
  16,000 deaths (US/yr)
  100,000 hospitalizations (US/yr)
 
12

 
The Topical NSAID Market
 © Imprimis Pharmaceuticals, Inc. | 13
 
13

 
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
 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
Per Dose Quantity
3g
4g
Dose Frequency
BID (2X Daily)
QID (4X Daily)
API
10% Ketoprofen
1% Diclofenac
COX Selectivity
Cox 1
Cox 2
Smell
Neutral
Insect Repellant
Tactile
Smooth
Greasy
 
14

 
Impracor Phase 3 Program
Initial Phase 3 Trial
 Removing subjects who should not have entered the trial: p=0.038
 Remove subjects who did not comply with the protocol: p=0.034
New Acute Pain Clinical Trials to Achieve FDA Approval
 Two adequate and well controlled acute pain trials
 Analgesic Solutions (Dr. Nathaniel Katz) design/execute program
 Use patented tools and methods to reduce placebo effect
 Rapid trial enrollment from “banking” of qualified patients
 Seek “sprains, strains and joint pain” label
 Could be the only acute pain topical NSAID (if FDA approved)
 © Imprimis Pharmaceuticals, Inc. | *
Phase 3 Clinical Trials Planned - Mid 2013
Initial Trial Data - Q1 2014
 
15

 
ImpracorCommercialization
 Capture existing compounded topical ketoprofen market
  Doctors prefer FDA approved product
  Patients prefer insurance reimbursement
  Potentially more margin for pharmacies for FDA-approved
 product
  Option to utilize PCCA member network to launch in US
 Out-license and compete against Voltaren in the large and
 growing
US topical NSAID market
  Benefit from format, feel, potency, dosing & smell
 advantages
 © Imprimis Pharmaceuticals, Inc. | *
 
16

 
Impracor Intellectual Property
FDA Exclusivity
FDA protection with up to 3 years of new drug exclusivity
“Paragraph IV” claims can prevent generics for up to 30 months
*** FDA “High Hurdles” for Topical Generics
Voltaren - off exclusivity and off patent for years - no generics
There are currently no generics in the topical NSAID market:
  FDA Guidance: Voltarengenerics must complete clinical studies prior to ANDA
  Generic drug companies are not in the business of conducting clinical trials
Conclusion: Bioequivalence for an ANDA for topical drugs is difficult to establish
 USPTO Protections
  Core Accudel™ US/Canadian patents issued
  New Impracor™ packaging applications filed
 © Imprimis Pharmaceuticals, Inc. | *
 
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
President: 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
 © 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 14, 2013
(Unaudited)
Percent
Common Shares
8,888,250
82.58%
Total Restricted Stock Units
200,000
1.86%
Total Options & Warrants - Weighted Avg. Ex. Price $5.49
1,675,487
15.56%
Total Common Shares - Diluted
10,763,737
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
1 gram
3 x per day =
3 grams/day
Safe / Cutaneous
Elegant Formulation
Convenient / Cream
Accudel Delivery System
Local AEs 1-2%
Seeking acute
musculoskeletal pain label
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

 
Relative COX-1/COX-2 Selectivity
Vane S J Thorax 2000;55:S3-S9
5-50 fold
COX-2
selective
<5-fold
COX-2
selective
-3
-2
-1
0
1
2
3
 © Imprimis Pharmaceuticals, Inc. | A9
 
32

 
Additional Impracor
Clinical Materials
 © Imprimis Pharmaceuticals, Inc. | A10
 
33

 
Topical NSAIDs in Acute OA Knee Pain Model
 © Imprimis Pharmaceuticals, Inc. | A11
 
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.
 
34

 
Retrospective Analysis of 1st Phase 3 Study
p = 0.038
mITT ** (n=326)
Study Design Error
ITT * (n=361)
Mean reduction from baseline in mm (100 mm Visual Analogue Scale)
mm
“Once randomized, you’re analyzed”  p = 0.087
* ITT = Intent-to-treat (ITT) population
**  mITT = Modified ITT of ITT patients - 35 met study entry criteria, but were excluded from ITT due to exclusionary criteria:
 (1) misdiagnosis, (30) positive drug screen, (4) other lab values at baseline making the patient ineligible for the trial
***  mPP = Modified per protocol (mPP) analysis of mITT patients -- who complied with the protocol? (52) improperly dosed,
 (22) no valid Day 3 primary endpoint assessment, and (4) were misdiagnosed
Design & Execution Optimization Lead to Statistical Significance (p = <0.05)
 
mPP *** (n=250)
Study Mgmt Errors
p = 0.034
 © Imprimis Pharmaceuticals, Inc. | A12
 Change from baseline
 in pain intensity
 during daily activities
 over the past 24
 hours on Day 3 Visit
 (Day 3, +1 or +2 days)
 
 
35

 
New Impracor Phase 3 Program: 1H 2013
Old Phase 3 Trial
New Phase 3 Trial
Many sprains and strains trials have failed
 Acute OA flare (as a pain model) provides a more
 reliable population with better chance for separation
High placebo responses
 Utilize analgesia-specific proprietary implements and
 methodologies to identify placebo responders
Insufficient monitoring for patient eligibility
 Invest in trial design and management
 Use only experienced pain trial investigators
Patients were entered into the ITT up to 72 hours
after injury
 OA flare model designed for NSAID “wash-out” and
 immediate randomization of eligible patients
People were allowed in if they had 6/10 pain level
over last 24 hours - regardless of pain at baseline
 OA flare model has defined entry criteria for pain
 intensity after NSAID “wash-out” and before
 randomization
30 subjects used un-allowed drugs
 Local laboratory for eligibility (drugs, liver, kidney,
 hematology)
Major dosing compliance problems related to
smaller size of tube orifice vs. applicator card box
 Provide scales and weigh tubes at any office visit
 © Imprimis Pharmaceuticals, Inc. | A13
 
36

 
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. | A14
 
37

 
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. | A15
1g, 3x daily
180mg, 2x daily
4g, 4x daily
40 drops, 4x daily
**
**
**
**
**
*
*
 
38

 
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. | A16
Orudis**
 
39

 
Clear Separation of Data Day 4 Onwards
Mean Change from Baseline in 3X/daily
 Pain Intensity Prior to Medication (from Patient Diary)
All ITT patients (n=361)
* =.statistically significant
 © Imprimis Pharmaceuticals, Inc. | A17
p = 0.041*
 
40

 
We Believe We Know What Body Part to Study
Day 7
n=77
p=0.0396
Knees and Adjacent Muscle Injuries
 © Imprimis Pharmaceuticals, Inc. | A18
Average Change in Pain Intensity from Baseline
 
41

 
Phase 1/2 Study - Investigator IND Efficacy by Assessing DOMS
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
Time
0h
24h
48h
0
1
2
3
4
5
6
Impracor
Placebo
Time
0h
24h
48h
0
1
2
3
4
5
6
Impracor
Placebo
VAS muscle soreness means ± SE 0, 24 and 48 hours,
significantly less soreness in the Impracor vs placebo group
(p=0.0118) between 24 and 48 hours
VAS muscle soreness means ± SE at 0, 24 and 48 hours.
Significantly less soreness in the Impracor vs placebo
(p=0.0104) between 24 and 48 hours
No Adverse Events Reported
p=0.0118
p=0.0104
Either Active o (both legs) Placebo
n=16
1/2 Active/Placebo on R or L Legs
n=16
 © Imprimis Pharmaceuticals, Inc. | A19
 
42

 
Additional Corporate
Information
 © Imprimis Pharmaceuticals, Inc. | A20
 
43

 
Board of Directors
Robert J. Kammer, D.D.S.
Managing Member of financial group that restructured Imprimis
Active Clinical Research & Consulting Practice
30+ Years Clinical Practice - Diplomate, American Board of Orofacial Pain
Retired Associate Professor & Course Director - Orofacial Pain, University of Colorado
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 $7.95M New Equity Investment and PCCA transaction
Paul Finnegan, M.D., M.B.A.
13+ Years Commercialization and Development Experience
Ops Experience: Avalon Ventures, Alexion, Pharmacia/Searle); Univ. of Chicago MBA
Senior Positions: Avalon Ventures, Alexion Pharmaceuticals, Pharmacia/Searle/Monsanto
Drugs: Celebrex, Bextra, Arthrotec, Soliris, Inspra and Aldactone/Soldactone
Jeff Abrams, M.D.
Founder and Director since 1998
Practicing primary care clinician for 20+ years
Co-developer of our Accudel drug delivery technology and Impracor topical NSAID
Stephen Austin, C.P.A.
Audit Committee Chairman; Board service on over 12 boards and related board committees
Partner at 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
 © Imprimis Pharmaceuticals, Inc. | A21
 
44

 
Balance Sheet
ASSETS
 
December 31, 2012
Current Assets
 
 
 
Cash and cash equivalents
$
10,035,615
 
Other assets
 
670,381
 
 
TOTAL ASSETS
$
10,705,996
LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
Accounts payable and accrued expenses
$
709,559
 
 
TOTAL LIABILITIES
 
709,559
Stockholder’s Equity
 
 
 
Common stock, $0.001 par value, 395,000,000 shares
authorized,
 
 
 
 
6,772,066 shares issued and outstanding
 
6,772
 
Additional paid-in capital
 
34,093,933
 
Deficit accumulated during the development stage
 
(24,104,268)
 
 
TOTAL STOCKHOLDERS' EQUITY
 
9,996,437
 
 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
10,705,996
 © Imprimis Pharmaceuticals, Inc. | A22
(Abbreviated)
 
45

 
Imprimis 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
 
46