Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (August 2017)
31 slides from Ani Pharmaceuticals's investor presentation, Aug 8, 2017
Slide 1: A Specialty Pharmaceutical Company: Corporate Presentation August 2017
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation August 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: Experienced Senior Management Team
Experienced Senior Management Team 3 With ANI Since Previous Affiliation Arthur S Przybyl President and CEO 2009 Akorn Stephen Carey VP, Finance and CFO 2016 Par Pharmaceutical James Marken SVP, Operations & Prod. Development 2007 Solvay Robert Schrepfer SVP, BD and Specialty Sales 2013 Healthcare V
Slide 4: Building a Stable Base with Diversified Growth
Building a Stable Base with Diversified Growth What we do: Acquire, develop, manufacture and commercialize GENERIC Rx products Acquire, manufacture and commercialize MATURE BRAND Rx products Provide high quality CONTRACT MANUFACTURING services to select clients Our strategy: Assemble a portfolio of
Slide 5: Three Platforms Form Strong Base Business
Three Platforms Form Strong Base Business 5 Generic Rx Brand Rx CMO Company estimates, IMS Health – July 2017 • 23 commercial products • 2Q17 net revenues: $31.5M (+40% vs. PY; +19% vs.1Q17) • 71 Pipeline products – 40 previously approved and can be re - commercialized via CBE30 or Prior Approval Su
Slide 6: Financial Highlights - 2Q and YTD 2017
Financial Highlights - 2Q and YTD 2017 Posted record quarterly Net Revenue, Adjusted non - GAAP EBITDA and Adjusted non - GAAP EPS 30 commercial product families as of June 30, 2017, up from 16 at the beginning of 2016 Quarterly net revenues increased 43% from prior year Quarterly adjusted non - GAA
Slide 7: Financial Highlights - 2Q Net Revenues
Financial Highlights - 2Q Net Revenues Generic sales gains driven by eight products launched during 2016 Brand sales gains reflect the late February 2017 introduction of InnoPran XL ® and Inderal ® XL Contract manufacturing reflects timing and volume of customer orders 7 Note: Figures may not foot /
Slide 8: Financial Highlights - YTD Net Revenues
Financial Highlights - YTD Net Revenues Generic sales gains driven by eight products launched during 2016 Brand sales gains reflect April 2016 launch of Inderal ® LA and the late February 2017 introduction of InnoPran XL ® and Inderal ® XL Contract manufacturing reflects timing and volume of custome
Slide 9: 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 in our Corticot
Slide 10: Commercial Products Growth Led by New Product Introductions
$30 $56 $76 $129 $8 $27 $43 $61 7 10 16 25 30 0 5 10 15 20 25 30 $0 $30 $60 $90 $120 $150 $180 $210 2013 2014 2015 2016 2017 Net Revenues Adjusted EBITDA Commercial Products Growth Led by New Product Introductions 10 ($s millions) Net Revenues $181 - $190 Adj. EBITDA $73.1 - $77.2 * * 30 Commercial
Slide 11: Sales and Marketing Overview
11 Sales and Marketing Overview
Slide 12: Generic Rx Product Portfolio: 2016 & 2017 Product Introductions
Propranolol ER Capsules (AG) Generic Rx Product Portfolio 2016 & 2017 Product Introductions Diphenoxylate Atropine (June 2017) Erythromycin Ethylsuccinate Fenofibrate Capsules (AG) HC Cream, for rectal use Indapamide (April 2017) Lithium Carbonate ER (AG) Mesalamine Enema (AG) Nilutamide Tablets Oxy
Slide 13: Generic Rx Product Portfolio: Foundational Products
Generic Rx Product Portfolio Foundational Products (launched prior to 2016) 13 (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 14: 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 ▪ $26.4 million of full year 2016 net sales ▪ $19.7 million first half 201
Slide 15: Brand Rx: InnoPran XL and Inderal XL
Brand Rx InnoPran XL ® and Inderal ® XL 15 Two additional hypertension brands acquired 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) Second quarter of 2017 was fi
Slide 16: Contract Manufacturing and Other
Contract Manufacturing and Other 16 Contract manufacturing ▪ $5.5 million of full year 2016 and $3.3M of first half 2017 net revenues ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Contract services and other ▪ $1.4 million of full year 2016 and
Slide 17: Business and Product Development Overview
17 Business and Product Development Overview
Slide 18: Business Development Activity – Generic Products
Business Development Activity – Generic Products 18 NOTES DATE ANI MANUF APPROVED COST ($M) G e n e r i c s Commercial May-16 P P 1% and 2.5% HC Cream to date, 1 product commercialized Aug-15 $0.0 Rowasa® AG (Partnership with Meda) Commercial Jan-16 P $10.0 Lipofen® AG & P P $1.0 IDT Partnership (18
Slide 19: Business Development Activity – Brand Products
Business Development Activity – Brand Products 19 B r a n d s Commercial Feb-17 P (propranolol ER capsules) Pipeline Dec-16 P P Pipeline May-15 P Lithobid® (lithium carbonate tablets) $20.0 Inderal® XL (propranolol ER capsules) Commercial Feb-17 P $31.0 InnoPran XL® $0.0 Brethine® (terbutaline table
Slide 20: Product Development Pipeline
20 Product Development Pipeline Generic Product Pipeline 71 products – 40 can be re - commercialized via CBE30 or Prior Approval Supplement Addressable market of pipeline = $ 2.1B Brand Product Pipeline 5 products – Cortrophin Gel, Cortrophin - Zinc, Vancocin ® Oral Solution, Brethine ® tablets and
Slide 21: Cortrophin - A Compelling Strategic Opportunity
Cortrophin - A Compelling Strategic Opportunity Regulatory and Development Considerations Approved NDAs/Discontinued Marketing: Clear and abbreviated pathway to re - commercialization Acquired: NDAs, DMF* and other documentation (e.g. batch records, historical data) 21 Value Creation Provides patien
Slide 22: Cortrophin - Path to Re-Commercialization
Cortrophin - Path to Re - Commercialization 22 Modernize Analytical Methods Manufacture API File sNDA Manufacture Drug Product Finalize Regulatory Strategy Engage FDA Source Pig Pituitary Build Dedicated ANI Team Acquisition Closed Key Steps • Establish pig pituitary supply chain • Successfully manu
Slide 23: Key Re-commercialization Milestones
Key Re - commercialization Milestones 23 Duration Status Additional Details Manufacture small - scale batch of corticotropin API 4 mos. Complete • Initial batch yields similar to historical yields • Analytical method development and testing ongoing • Initiate stability testing Select drug product CM
Slide 24: Manufacturing Overview
24 Manufacturing Overview
Slide 25: Manufacturing – Main Street Facility
25 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 space fo
Slide 26: Manufacturing – IDC Road Facility
26 Manufacturing – IDC Road Facility Location: Baudette, Minnesota ▪ Fully - contained high potency facility with capabilities to manufacture hormone, steroid, and oncolytic products ▪ 47,000 square feet of manufacturing, packaging, and warehouse facilities ▪ 100 nano - gram per eight - hour time we
Slide 27: 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 $190 m
Slide 28: Appendix A
28 Appendix A
Slide 29: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 29 2017 2016 2017 2016 Net Income 2,681$ 1,125$ 3,833$ 2,471$ Add back Interest expense, net 3,025 2,830 5,957 5,612 Other expense, net 19 12 37 10 Provision for income taxes 1,269 1,227 1,792 2,767 Depreciation and amortization 7,101 5,956 13,807 10,565 Add back Stock-base
Slide 30: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 30 2017 2016 2017 2016 Net Income 2,681$ 1,125$ 3,833$ 2,471$ Add back Non-cash interest expense 1,774 1,757 3,566 3,482 Depreciation and amortization expense 7,101 5,956 13,807 10,565 Stock-based compensation 1,807 2,217 3,193 3,322 Excess of fair value over cost of acquir
Slide 31: U.S. GAAP Reconciliations: Non-GAAP Measures in 2017 Guidance
U.S. GAAP Reconciliations 31 Non - GAAP Financial Measures included in 2017 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 (August 2017) on 6ix