Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Merger or Acquisition (September 2015)
10 slides from Ani Pharmaceuticals's merger presentation, Sep 21, 2015
Slide 1: Acquisition of Corticotropin and Corticotropin-Zinc NDAs
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Acquisition of Corticotropin and Corticotropin - Zinc NDAs September 2015
Slide 2: Forward-Looking Statements
2 Forward - Looking Statements To the extent any statements made in this presentation deal with information that is not historical, these are forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Such statements include, but are not limited to, sta
Slide 3: ANI Mission
3 ANI Mission ANI Pharmaceuticals is an integrated specialty pharmaceutical company developing, manufacturing and marketing branded and generic prescription pharmaceuticals. We focus on niche and high barrier to entry opportunities including controlled substances, anti - cancer (oncolytics), hormone
Slide 4: Acquisition Overview
4 Acquisition Overview Assets ▪ NDA 008975 Corticotropin 40 units/ mL and 80 units/ mL ▪ NDA 009854 Corticotropin - zinc hydroxide 40 units/ mL Terms ▪ $75 million in cash ▪ A percentage of future net sales Structure ▪ ANI to acquire and commercialize assets via foreign subsidiary Timing ▪ Expected
Slide 5: Compelling Strategic Opportunity
5 Compelling Strategic Opportunity Provides patients, physicians and payors with valuable therapeutic option Large and growing U.S. market with concentrated prescriber base ▪ H.P. Acthar ® gel - $1 billion in annual sales with double digit script growth* ▪ Broad label with minimal penetration – Use
Slide 6: Current Corticotropin Label(s) Similar to H.P. Acthar
6 Current Corticotropin Label(s) Similar to H.P. Acthar ® H.P. Acthar® Label - H.P. Acthar ® Gel is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection Corticotropin Label(s) - Corticotro
Slide 7: Steps to Re-Commercialization
7 Steps to Re - Commercialization Regulatory ▪ Meet with FDA to initiate re - activation of NDA(s) ▪ CMC – provide documentation to justify any changes to site, suppliers, DMF ▪ Drug substance/drug product – demonstrate similarity to product manufactured under approved NDA ▪ Label – match H.P. Actha
Slide 8: Products Aligned with ANI Acquisition Strategy
8 Products Aligned with ANI Acquisition Strategy 8 ANI Manufactured Pain Management Potent Compounds Complex Formulations
Slide 9: Summary - Unique Opportunity / Long Term Value
9 Summary - Unique Opportunity / Long Term Value Approved NDAs ▪ Corticotropin: 40 units/ mL and 80 units/ mL ▪ Corticotropin - zinc hydroxide: 40 units/ mL $1 billion market currently dominated by a single product Adds significant long - term value driver to ANI platform Tax advantaged structure 9
Slide 10: Conclusion
10 Conclusion 10
ANI Pharmaceuticals — Merger or Acquisition (September 2015) on 6ix