Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (November 2016)
25 slides from Ani Pharmaceuticals's investor presentation, Nov 14, 2016
Slide 1: A Specialty Pharmaceutical Company – Corporate Presentation November 2016
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation November 2016
Slide 2: Forward-Looking Statements
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, statem
Slide 3: Mission and Strategy
3 Mission and Strategy ANI Pharmaceuticals is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing , manufacturing and marketing high quality branded and generic prescription pharmaceuticals. Our dedicated team of R&D, business development, manufa
Slide 4: Senior Management Team
Senior Management Team 4 With ANI Yrs Industry Since Experience Arthur Przybyl President and CEO 2009 25+ Steve Carey VP, Finance and CFO 2016 20+ Robert Schrepfer SVP, Business Development and 2013 15 Specialty Sales Jim Marken SVP, Operations and Product 2007 20+ Development David Sullivan VP, Qua
Slide 5: Financial Highlights – 3Q and YTD 2016
Financial Highlights – 3Q and YTD 2016 Record quarterly results on the strength of nine new product launches in the first three quarters of 2016: ▪ Net revenues up 93% from prior year and 23% from Q2 2016 ▪ Adjusted non - GAAP EBITDA up 41% from prior year and 6% from Q2 2016 (1) See Appendix A for
Slide 6: Financial Highlights – 3Q Net Revenues
Financial Highlights – 3Q Net Revenues Generic sales gains driven by 10 product launches between the fourth quarter of 2015 and the first nine months of 2016 Brand sales reflect April 2016 launch of Inderal ® LA Contract services previously reflected royalty income on authorized generic of Vancocin
Slide 7: 2016 Guidance
2016 Guidance Fourth quarter catalysts include: ▪ Continued execution of generic product launches 2017 Guidance will be released late February 2017, in conjunction with the announcement of fourth quarter results (1) See Appendix A for note regarding US GAAP reconciliations 7 ($ in millions except EP
Slide 8: Historical 5-Year Revenue and Adjusted EBITDA Growth
$(10) $- $10 $20 $30 $40 $50 $60 $70 $80 2010 2011 2012 2013 2014 2015 Revenues EBITDA Historical 5 - Year Revenue and Adjusted EBITDA Growth 8 $s in millions
Slide 9: Sales and Marketing Overview
9 Sales and Marketing Overview
Slide 10: Generic Rx Product Portfolio – 2016 Launches
Generic Rx Product Portfolio 2016 Launches Benztropine Mesylate Erythromycin Ethylsuccinate Fenofibrate Capsules (AG) HC Cream, for rectal use Hydroxyprogesterone Caproate Injection USP Mesalamine Enema (AG) Nilutamide Tablets Oxycodone Capsules Propranolol ER Capsules (AG) 10 Continued broadening o
Slide 11: Generic Rx Product Portfolio – Foundational Products
Generic Rx Product Portfolio Foundational Products (launched prior to 2016) 11 (AG) = Authorized Generic EE/MT Tablets Etodolac Capsules Flecainide Tablets Fluvoxamine Maleate Tablets (AG) HC Enema (AG) Methazolamide Tablets Metoclopramide Solution Nimodipine Capsules Opium Tincture Oxycodone Oral S
Slide 12: Brand Rx Product Portfolio
Brand Rx Product Portfolio Lithobid ® Tablets Bipolar Disorder Vancocin ® Capsules C. difficile - Associated Diarrhea Cortenema ® U lcerative Colitis Reglan ® Tablets Gastroesophageal Reflux Inderal ® LA Capsules Hypertension ▪ Inderal ® LA launched April 2016 ▪ $6.8 million of total brand Q3 2016 n
Slide 13: Contract Manufacturing and Other
Contract Manufacturing and Other 13 Contract manufacturing ▪ $1.4 million of Q3 2016 net revenues ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Contract services and other ▪ $0.1 million of Q3 2016 net revenues ▪ Product development services, la
Slide 14: Business and Product Development Overview
14 Business and Product Development Overview
Slide 15: Business Development Activity - Generics
Business Development Activity - Generics 15
Slide 16: Business Development Activity - Brands
Business Development Activity - Brands 16
Slide 17: Product Development Pipeline
17 Product Development Pipeline ANI Pipeline ▪ 78 products in development, total combined current market: $3.7 billion (1) ▪ 53 products were acquired and of those, ANI believes 46 can be commercialized based on either a CBE - 30 or PAS Corticotropin Re - commercialization Update ▪ Expert team assem
Slide 18: Manufacturing Overview
18 Manufacturing Overview
Slide 19: Manufacturing – Main Street Facility
19 Manufacturing – Main Street Facility Location: Baudette , Minnesota ▪ 52,000 square feet of manufacturing , packaging, and warehouse facilities ▪ Rx solutions , suspensions , topicals , tablets , and capsules ▪ DEA - licensed for Schedule II controlled substances ▪ 17,000 square feet of laborator
Slide 20: Manufacturing – IDC Road Facility
20 Manufacturing – IDC Road Facility Location: Baudette, Minnesota ▪ Fully - contained h igh potency facility with capabilities to manufacture h ormone , steroid , and oncolytic products ▪ 47,000 square feet of manufacturing, packaging , and warehouse facilities ▪ 100 nano - gram per eight - hour we
Slide 21: Summary
Summary ANI is an integrated specialty generic pharmaceutical company with: ▪ Profitable base business generating organic growth – 2016 Annual guidance (1) □ Net revenues of $128 million to $134 million □ Adjusted non - GAAP EBITDA (2) of $59 million to $63 million □ Adjusted non - GAAP Net Income P
Slide 22: Appendix A
22 Appendix A
Slide 23: U.S. GAAP Reconciliations – Adjusted EBITDA
U.S. GAAP Reconciliations 23 2016 2015 2016 2015 Net Income 2,543$ 4,559$ 5,014$ 12,499$ Add back Interest expense, net 2,856 2,766 8,468 8,240 Other expense/income, net 21 28 31 (40) Provision for income taxes 2,501 1,098 5,268 5,733 Depreciation and amortization 5,966 2,047 16,531 4,789 Add back S
Slide 24: U.S. GAAP Reconciliations – Adjusted Net Income
U.S. GAAP Reconciliations 24 2016 2015 2016 2015 Net Income 2,543$ 4,559$ 5,014$ 12,499$ Add back Tax provision 2,501 1,098 5,268 5,733 Depreciation and amortization expense 5,966 2,047 16,531 4,789 Non-cash interest expense 1,782 1,721 5,264 5,109 Stock-based compensation 1,365 1,120 4,687 2,717 Ex
Slide 25: U.S. GAAP Reconciliations – 2016 Guidance Measures
U.S. GAAP Reconciliations 25 Non - GAAP Financial Measures included in 2016 Guidance The Company's fiscal 2016 guidance for adjusted non - GAAP EBITDA and adjusted non - GAAP net income per diluted share is not reconciled to the most comparable GAAP measure. This is due to the inherent difficulty of
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