Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (December 2018)
25 slides from Ani Pharmaceuticals's investor presentation, Dec 27, 2018
Slide 1: Corporate Presentation December 2018
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation December 2018
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 ▪ 72 pipeline products; 50 previously approved ▪ Total annual market size = $3.3B Branded Drugs ▪ 11 commercial products ▪ 3 pipeline products previously approved ▪ Total annual market size = $1.2B Contract Development & Manuf. ▪ 24 clients r
Slide 4: Experienced Senior Management Team
Name Role Industry Experience Joined ANI Previous Affiliation Arthur Przybyl President and CEO 25+ years 2009 Stephen Carey VP, Finance and CFO 20 2016 Robert Schrepfer SVP, BD and Specialty Sales 15 2013 James Marken SVP, Operations & Prod. Development 20 2007 David Sullivan, PhD VP, Quality Operat
Slide 5: Financial Highlights - 3Q and YTD 2018
Financial Highlights - 3Q and YTD 2018 As compared with prior year: Net revenues increased 5% in 3Q and 10% YTD Adjusted non - GAAP EBITDA increased 4% in 3Q and 14% YTD Adjusted non - GAAP diluted earnings per share increased 16% in 3Q and 32% YTD (1) See Appendix A for US GAAP reconciliations 5 ($
Slide 6: Financial Highlights - 3Q and YTD 2018
Financial Highlights - 3Q and YTD 2018 Year - to - date results include: Generic sales declines driven by volume decreases for Fenofibrate, EEMT, and Nilutamide and price decreases for Propranolol ER, tempered by Q2 2018 product launches and impact of the Q2 2017 launch of Diphenoxylate Hydrochlorid
Slide 7: Full Year 2018 Guidance
Full Year 2018 Guidance Forecast results assumes: Revenues and expenses related to our December 29, 2017 acquisition of the NDAs and U.S. product rights for Atacand ® , Atacand HCT ® , Arimidex ® , and Casodex ® and August 6 th acquisition of WellSpring Pharma Services Maximizing the potential of ou
Slide 8: Growth Led by New Product Introductions
$30 $56 $76 $129 $177 $200 ** $8 $27 $43 $61 $74 $85 ** 7 10 16 25 31 42 0 5 10 15 20 25 30 35 40 $0 $30 $60 $90 $120 $150 $180 $210 $240 $270 2013 2014 2015 2016 2017 2018 Guidance Net Revenues Adjusted EBITDA Commercial Products * Growth Led by New Product Introductions 8 ($’s in millions) * Produ
Slide 9: Strong Capital Position
Strong Capital Position 9 $44.1 million of cash as of September 30, 2018, up 40% from year end ▪ YTD 2018 cash flow from operations of $39.8 million and free cash flow of $35.1 million Net leverage of 2.0x as of September 30, 2018, based upon mid - point of 2018 guidance Recently completed 5 - year,
Slide 10: Generic Rx - $83.7M Net Sales YTD
Generic Rx - $83.7M Net Sales YTD Strong market share position – top 10 products average approximately 48% share as of October 29, 2018 Substantial Authorized Generic portfolio of 9 commercial products Contracts with all 3 major buying consortia – Red Oak, WBAD, and ClarusONE To date, ANI has re - l
Slide 11: Generic Rx - Impax/Amneal Transaction
Pipeline: Erythromycin IR tablets Diclofenac - Misoprostol DR tablets* Generic Rx - Impax/Amneal Transaction Commercialized: Ezetimibe - Simvastatin tablets Felbamate tablets Desipramine tablets Approved ANDAs: Aspirin/Dipyridamole ER capsules Methylphenidate ER tablets 11 Acquired six generic produ
Slide 12: Generic Rx - Pipeline
12 Generic Rx – Pipeline ANDA Pipeline includes 72 products ▪ 51 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 date 1Q 20
Slide 13: Brand Rx - $41.7M Net Sales YTD
Brand Rx - $41.7M Net Sales YTD 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 Atacand ® and Atac
Slide 14: Brand Rx - Pipeline
14 Brand Rx – Pipeline (1) Based on Company estimates and IQVIA data Total annual market size: $1.2 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 - $5.5M Net Sales YTD
Contract Manufacturing - $5.5M Net Sales YTD 16 Contract manufacturing ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Recently acquired WellSpring Pharma Services - CDMO ▪ Currently generating approximately $11M in annual revenues ▪ 20 customers
Slide 17: WellSpring Pharma Services Acquisition
WellSpring Pharma Services Acquisition 17 Transaction Details - $18 million, cash at close Location: Oakville, Canada (near Toronto) Employee base: ~100 Strategic Rationale – Scale and Synergy Additional tech transfer site to accelerate re - commercialization of ANI’s pipeline of approved generic AN
Slide 18: 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 19: Manufacturing Overview - Oakville, Canada
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 20: ANI Royalty Income - $13.6M Net Revenues YTD
ANI Royalty Income - $13.6M Net Revenues YTD 20 YTD Royalty income primarily reflects: ▪ $11.1 million on sales of Atacand ® , Atacand HCT ® , Arimidex ® , and Casodex ® ▪ $1.4 million for sales and milestones on Yescarta ® Yescarta ® Royalty ▪ YTD 2018, ANI recognized $1.4 million in royalties and
Slide 21: 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 ▪ 2018 Annual guidance (1) – Net revenues of $195 million
Slide 22: Appendix A
22 Appendix A
Slide 23: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 23 2018 2017 2018 2017 Net Income 5,037$ 4,720$ 10,064$ 8,553$ Add back Interest expense, net 3,768 3,052 11,132 9,009 Other income/(expense), net (20) (95) 71 (58) Provision for income taxes 1,329 1,654 2,647 3,446 Depreciation and amortization 8,548 7,099 25,056 20,906 Ad
Slide 24: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 24 2018 2017 2018 2017 Net Income 5,037$ 4,720$ 10,064$ 8,553$ Add back Non-cash interest expense 1,980 1,789 5,839 5,355 Depreciation and amortization expense 8,548 7,099 25,056 20,906 Acquired IPR&D expense - - 1,335 - Stock-based compensation 1,795 1,475 4,954 4,668 Exce
Slide 25: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 25 Non - GAAP Financial Measures included in 2018 Guidance The Company's fiscal 2018 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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