Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (March 2019)
24 slides from Ani Pharmaceuticals's investor presentation, Mar 15, 2019
Slide 1: A Specialty Pharmaceutical Company: Corporate Presentation March 2019
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation March 2019
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: Corporate Overview
Corporate Overview Generic Drugs ▪ 31 commercial products ▪ 103 pipeline products; 98 previously approved ▪ Total annual market size = $4.1B Branded Drugs ▪ 11 commercial products ▪ 3 pipeline products previously approved ▪ Total annual market size = $1.1B Contract Development & Manuf. ▪ 21 clients
Slide 4: Experienced Senior Management Team
Experienced Senior Management Team 4 Name Role Industry Experience Joined ANI Previous Affiliation Arthur Przybyl President and CEO 25 + years 2009 Stephen Carey VP, Finance and CFO 20 2016 Robert Schrepfer SVP, BD and Specialty Sales 15 2013 James Marken SVP, Operations & Prod. Development 20 2007
Slide 5: Financial Highlights - 4Q and Full Year 2018
Financial Highlights - 4Q and Full Year 2018 As compared with prior year: Net revenues increased 21% in 4Q and 14% YTD Adjusted non - GAAP EBITDA increased 13% in 4Q and 14% YTD Adjusted non - GAAP diluted earnings per share increased 22% in 4Q and 30% YTD (1) See Appendix A for US GAAP reconciliati
Slide 6: Financial Highlights - 4Q and Full Year 2018
Financial Highlights - 4Q and Full Year 2018 Year - to - date results include: Generic sales declines driven by volume decreases for Fenofibrate and Nilutamide, as well as sales decreases for Propranolol ER driven by price, tempered by 2018 product launches and impact of the Q2 2017 launch of Diphen
Slide 7: Full Year 2019 Guidance
Full Year 2019 Guidance Forecast results assumes: Full year revenues and expenses related to our August 6 th acquisition of WellSpring Pharma Services Inc. Continued investment in our Cortrophin ® Gel re - commercialization program. The above guidance range include approximately $14.5 million to $16
Slide 8: Commercial Products Growth Led by New Product Introductions
$56 $76 $129 $177 $202 $238 $27 $43 $61 $74 $84 $100 10 16 25 31 42 0 5 10 15 20 25 30 35 40 45 $0 $30 $60 $90 $120 $150 $180 $210 $240 $270 2014 2015 2016 2017 2018 2019 Guidance Net Revenues Adjusted EBITDA Commercial Products Growth Led by New Product Introductions 8 ($’s in millions) * Midpoint
Slide 9: Strong Capital Position
Strong Capital Position 9 $43.0 million of cash as of December 31, 2018, up 38% from prior year ▪ YTD 2018 cash flow from operations of $67.1 million and free cash flow of $61.3 million Net leverage of 1.5x as of December 31, 2018, based upon mid - point of 2019 guidance Recently completed 5 - year,
Slide 10: Generic Rx - $117.4M Net Sales for Full Year 2018
Generic Rx - $117.4M Net Sales for Full Year 2018 Strong market share position – top 10 products average approximately 50% share as of February 28, 2019 Substantial Authorized Generic portfolio of 9 commercial products Contracts with all 3 major buying consortia – Red Oak, WBAD, and ClarusONE To dat
Slide 11: Generic Rx - Recent Transactions
Generic Rx - Recent Transactions 11 * License , supply, and distribution agreement Impax / Amneal Acquired six generic products, three of which are currently marketed, and a license, supply, and distribution agreement for a seventh product from Impax Laboratories, Inc. as part of an FTC - required d
Slide 12: Generic Rx – Pipeline
12 Generic Rx – Pipeline ANDA Pipeline includes 103 products ▪ At least 57 can be re - commercialized via CBE - 30 or Prior Approval Supplement ▪ Leverage ANI’s three manufacturing sites to re - launch acquired ANDAs Key Pipeline Products Methylphenidate ER Tablets ▪ $1.3B market ▪ Estimated launch
Slide 13: Brand Rx - $60.6M Net Sales for Full Year 2018
Brand Rx - $60.6M Net Sales for Full Year 2018 13 Commercial Portfolio includes 11 Brand Products Inderal ® XL and InnoPran XL ® supported by active sampling, patient awareness campaigns and physician sales and marketing effort Launched Arimidex ® and Casodex ® in ANI label in July 2018 Launched Ata
Slide 14: Brand Rx – Pipeline
14 Brand Rx – Pipeline (1) Based on Company estimates and IQVIA data Total annual market size: $1.1 billion+ (1) Brand Pipeline includes three products ▪ Cortrophin ® Gel, Cortrophin - Zinc ® , and Vancocin ® Oral Solution ▪ All are FDA approved and can be re - commercialized via sNDA filing ▪ Vanco
Slide 15: Cortrophin Gel Re-commercialization Milestones
Cortrophin ® Gel Re - commercialization Milestones 15 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 Select drug product CMO 6 mos. Complet
Slide 16: Contract Manufacturing - $9.1M Net Sales for Full Year 2018
Contract Manufacturing - $9.1M Net Sales for Full Year 2018 16 Contract manufacturing – Baudette, Minnesota ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Contract manufacturing – Oakville, Ontario ▪ Currently generating approximately $10M in ann
Slide 17: Manufacturing Overview – Baudette, Minnesota
Main Street Facility – 130K ft 2 IDC Road Facility – 47K ft 2 Overview ▪ 57,000 ft 2 of manufacturing, packaging, and warehouse ▪ Recently completed 5,500 ft 2 warehouse expansion includes additional schedule CII vault & CIII cage space ▪ 17,000 ft 2 of laboratory space for product development and a
Slide 18: Manufacturing Overview – Oakville, Ontario
Canadian Facility – 101K ft 2 Overview ▪ 101,000 ft 2 of manufacturing, packaging, lab, warehouse, and administrative space ▪ US FDA and Health Canada inspected ▪ Controlled drugs and substance license ▪ Ability to expand footprint Capabilities ▪ Rx solutions, suspensions, topicals, tablets, and cap
Slide 19: ANI Royalty Income - $14.5M Net Revenues for fiscal 2018
ANI Royalty Income - $14.5M Net Revenues for fiscal 2018 19 YTD Royalty income primarily reflects: ▪ $10.7 million on sales of Atacand ® , Atacand HCT ® , Arimidex ® , and Casodex ® ▪ $1.8 million for sales and milestones on Yescarta ® Yescarta ® Royalty ▪ YTD 2018, ANI recognized $1.8 million in ro
Slide 20: Summary
Summary ANI is an integrated specialty generic pharmaceutical company with: ▪ Profitable base business generating organic growth ▪ Strong capital position ▪ Experienced management team ▪ North American based manufacturing assets and expertise ▪ 2019 Annual guidance (1) – Net revenues of $231 million
Slide 21: Appendix A
21 Appendix A
Slide 22: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 22 2018 2017 2018 2017 Net Income/(Loss) 5,430$ (9,629)$ 15,494$ (1,076)$ Add back Interest expense, net 3,626 3,026 14,758 12,035 Other (income)/expense, net, less loss on and expense on repurchase of convertible debt (90) 3 (19) (55) Provision for income taxes 1,910 13,97
Slide 23: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 23 2018 2017 2018 2017 Net Income/(Loss) 5,430$ (9,629)$ 15,494$ (1,076)$ Add back Non-cash interest expense 1,903 1,758 7,741 7,113 Depreciation and amortization expense 8,686 7,022 33,742 27,928 Acquired IPR&D expense - - 1,335 - Stock-based compensation 1,828 1,422 6,782
Slide 24: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 24 Non - GAAP Financial Measures included in 2019 Guidance The Company's fiscal 2019 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
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