Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (March 2017)
28 slides from Ani Pharmaceuticals's investor presentation, Mar 14, 2017
Slide 1: A Specialty Pharmaceutical Company: Corporate Presentation March 2017
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation March 2017
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 Previous Affiliation Arthur Przybyl President and CEO 2009 25+ Akorn Stephen Carey VP, Finance and CFO 2016 20+ Par Pharmaceutical Robert Schrepfer SVP, Business Development and 2013 15 Healthcare Value Capital Specialty Sales James Mar
Slide 5: Financial Highlights - 4Q and Full Year 2016
Financial Highlights - 4Q and Full Year 2016 Record annual results on the strength of new product launches during 2016: 25 commercial product families, up from 16 at the beginning of 2016 Net revenues increased 112% from prior year in 4Q and 69% on full year basis Adjusted non - GAAP EBITDA increase
Slide 6: Financial Highlights - 4Q Net Revenues
Financial Highlights - 4Q Net Revenues Generic sales gains driven by products launched during 2016 (detailed on slide 11) Brand sales reflect April 2016 launch of Inderal ® LA 6 Note: Figures may not foot / cross - foot due to rounding. ($ in millions) 2016 2015 $ % Generic pharmaceutical products 2
Slide 7: Financial Highlights - 2016 Net Revenues
Financial Highlights - 2016 Net Revenues Generic sales gains driven by products launched during 2016 (detailed on slide 11) Brand sales reflect April 2016 launch of Inderal ® LA Contract manufacturing reflects timing and volume of customer orders Contract services and other previously reflected roya
Slide 8: 2017 Guidance
2017 Guidance Forecast results projected to be driven by: Annualization and continued operational focus on maximizing 2016 launches Expansion of our brand revenues with the addition of InnoPran XL ® and Inderal ® XL Execution of 2017 generic product launches Increasing the investment behind our Cort
Slide 9: Historical 5-Year Revenue and Adjusted EBITDA Growth
$- $20 $40 $60 $80 $100 $120 $140 2011 2012 2013 2014 2015 2016 Revenues EBITDA Historical 5 - Year Revenue and Adjusted EBITDA Growth 9 $s in millions
Slide 10: Sales and Marketing Overview
10 Sales and Marketing Overview
Slide 11: Generic Rx Product Portfolio - 2016 Product Introductions
Generic Rx Product Portfolio 2016 Product Introductions Erythromycin Ethylsuccinate Fenofibrate Capsules (AG) HC Cream, for rectal use Lithium Carbonate ER (AG) Mesalamine Enema (AG) Nilutamide Tablets Oxycodone Capsules Propranolol ER Capsules (AG) 11 Continued broadening of our product offerings ▪
Slide 12: Generic Rx Product Portfolio - Foundational Products
Generic Rx Product Portfolio Foundational Products (launched prior to 2016) 12 (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 13: 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 ▪ $26.4 million of brand net sales in 2
Slide 14: Brand Rx InnoPran XL and Inderal XL
Brand Rx InnoPran XL ® and Inderal ® XL 14 Two additional hypertension brands added in first quarter 2017: Purchased on February 23, 2017, for approximately $51 million Generated combined sales of $23.3 million in 2016 according to IMS Health data (gross sales basis)
Slide 15: Contract Manufacturing and Other
Contract Manufacturing and Other 15 Contract manufacturing ▪ $5.5 million of 2016 net revenues ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Contract services and other ▪ $1.4 million of 2016 net revenues ▪ Product development services, laborato
Slide 16: Business and Product Development Overview
16 Business and Product Development Overview
Slide 17: Business Development Activity - Generics
Business Development Activity - Generics 17 P $0.0 Acquisition of US Distr Rights Nimodipine & Omega Private P P $10.0 IDT Partnership (18 previously approved ANDAs) P $1.0 P P Rowasa AG (Partnership with Meda) US Distr Rights Private P Lipofen AG & 1% and 2.5% HC Cream US Distr Rights Private US Di
Slide 18: Business Development Activity - Brands
Business Development Activity - Brands 18 (lithium carbonate tablets) $11.0 Vancocin® $209.0Total P Private (vancomycin hydrochloride capsules) Acquisition P P STRUCTURE SOURCE STRATEGY ANI MANUF APPROVED COST ($M) $60.0 Inderal® LA (propranolol ER capsules) Private P P B r a n d s Acquisition Priva
Slide 19: Product Development Pipeline
19 Product Development Pipeline ANI Pipeline ▪ 78 products in development, total combined current market: $3.7 billion (1) ▪ 54 products were acquired and of those, ANI believes 47 can be commercialized based on either a CBE - 30 or PAS Corticotropin Re - commercialization Update ▪ Expert team assem
Slide 20: Manufacturing Overview
20 Manufacturing Overview
Slide 21: Manufacturing – Main Street Facility
21 Manufacturing – Main Street Facility Location: Baudette , Minnesota ▪ 52,000 sq. ft. 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 laboratory sp
Slide 22: Manufacturing – IDC Road Facility
22 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 ti
Slide 23: Summary
Summary ANI is an integrated specialty generic pharmaceutical company with: ▪ Profitable base business generating organic growth ▪ Strong capital position ▪ Experienced management team ▪ US - based manufacturing assets and expertise ▪ 2017 Annual guidance (1) – Net revenues of $181 million to $190 m
Slide 24: Appendix A
24 Appendix A
Slide 25: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 25 2016 2015 2016 2015 Net (Loss)/Income (1,080)$ 2,876$ 3,934$ 15,375$ Add back Interest expense, net 2,859 2,768 11,327 11,008 Other income/(expense), net 43 (1) 74 (41) (Benefit)/Provision for income taxes (524) 625 4,744 6,358 Depreciation and amortization 5,812 2,111 2
Slide 26: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 26 Three Months Ended Three Months Ended Three Months Ended Three Months Ended Year Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 December 31, 2016 Net Income/(Loss) 1,346$ 1,125$ 2,543$ (1,080)$ 3,934$ Add back Excess of fair value over cost of ac
Slide 27: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 27 2016 2015 2016 2015 Net (Loss)/Income (1,080)$ 2,876$ 3,934$ 15,375$ Add back (Benefit)/Provision for income taxes (524) 625 4,744 6,358 Depreciation and amortization expense 5,812 2,111 22,343 6,900 Intangible asset impairment charge 6,685 - 6,685 - Non-cash interest ex
Slide 28: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 28 Non - GAAP Financial Measures included in 2016 Guidance The Company's fiscal 2017 guidance for adjusted non - GAAP EBITDA and adjusted non - GAAP diluted earnings per share is not reconciled to the most comparable GAAP measure. This is due to the inherent difficulty of f
ANI Pharmaceuticals — Investor Presentation (March 2017) on 6ix