Monday, April 4, 2011

PCRX Due Diligence

Overview:

PCRX - Pacira Pharmaceuticals just recently went public through completion of IPO in February 2011. It is still relatively unknown and under the radar to many investors.

It has a blockbuster drug EXPAREL up for approval on 7/28/2011.
EXPAREL is a is a proprietary, long-acting bupivacaine product for postsurgical pain management.

PCRX has a SUPER LOW Float
17.2M Shares outstanding and 12M are owned by insiders/institutions, that leaves the float to be ONLY 5.2M

Cash on Hand: $64M. Plenty for the marketing and launch of EXPAREL. No worries for dilution.

EXPAREL is as close as you can get to a guarantee for FDA approval. Its very simple, EXPAREL is bupivacaine encapsulated in DepoFoam, both of which are already FDA Approved.

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Sales possibilities for EXPAREL

*Infiltration (PDUFA 7/28/2011):
24 Million procedure opportunities annually = $4.8 BILLION DOLLARS

*Nerve Block (phase 3 beginning Q4):
8 Million procedure opportunities annually = $1.6 BILLION DOLLARS

*Epidural Administration (recently completed phase 1):
6 Million procedure opportunities annually = $1.2 BILLION DOLLARS

***TOTAL OF $7.8 BILLION DOLLARS IN POTENTIAL SALES FOR EXPAREL

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Advantages of EXPAREL:

*EXPAREL provides continuous and extended postsurgical analgesia for up to 72 hours, compared with bupivacaine’s analgesic timeline of only 7 hours or less.

*EXPAREL will address a significant unmet medical need for a long-acting non-opioid postsurgical analgesic.

*Decreased opioid-related side effects
– Nausea, vomiting, constipation, urinary retention, pruritis, somnolence, respiratory depression

*Decreased hospital resource consumption
– Time from PACU to floor
– Nursing time to monitor opioid-related side effects and PCA

*Faster ambulation
– Less need for patients to be tethered to IV pole

*Faster hospital discharge
– Increased patient satisfaction

*Effective pain control for patients who do not tolerate opioids

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Excellent Efficacy and Safety Results:


Hemmorrhoidectomy Phase 3 trial - Met statistical significance all the way up to 72 hours.
Hemmorrhoidectomy Phase 2 Trial - EXPAREL dose-reponse trial with statistically significant results supporting the use of EXPAREL 300 mg dosage in the Phase 3 trial.

Bunionectomy Phase 3 trial - Met statistical significance at 2, 4, 8 and 48 hours. Note, in this trial a dose of only 120mg was used, while in the hemmorrhoidectomy 300mg was used.

A Phase 2 Trial showing efficacy, safety and pharmacokinetics of EXPAREL.
You can see many advantages EXPAREL has over bupivacaine.

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Proven Track Record for Development and Manufacturing of Commercially Successful Depofoam Products:  
Picara has two DepoFoam products already FDA approved, which are marketed by strategic partners:  http://www.pacira.com/products-pipeline.php

Picara's plans for EXPAREL:  "Pacira owns all product rights to EXPAREL for use in all markets. As such, the company believes the global opportunity for EXPAREL for use in the management of postsurgical pain presents a large addressable market opportunity. Based upon this opportunity, Pacira is pursuing commercial partnerships for EXPAREL in regions outside of the United States that will complement its direct sales efforts in the United States if EXPAREL is granted clearance by the governing regulatory bodies here and abroad."
  
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