Full Press Release Details
Imprimis Pharmaceuticals, Inc.
"A Unique Approach to 505(b)(2)"
Mark L. Baum, C.E.O.
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
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.
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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
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505(b)(2) Lower Risk | Higher Margin
Our mission is to develop proprietary drugs using the
FDA 505(b)(2) drug development pathway
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)
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Imprimis Development Model
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Imprimis Brings Innovation
from Pharmaceutical Compounders
to the >$300B U.S. Pharmaceutical Industry
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
Proprietary Drug Pipeline
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Drive Shareholder Value
Monetize vast 505(b)(2)
Selectively internal
Improve Patient Care
Novel drug administration
negative side effect
Increase therapeutic
Monetizing the PCCA Relationship
Step 1: Opportunity Matrix
X-Axis: Drug Administration
Reimbursement Landscape
Partner, Out-License
Imprimis Growth & Development Process
Out-License or Develop
Market Launch/Partner
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| 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. |
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Additional compounds in late stage assessment are in the therapeutic areas of
Pain and Sexual Dysfunction
Improving Patient Care:
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The Topical NSAID Market
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