Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (December 2019)
25 slides from Ani Pharmaceuticals's investor presentation, Dec 3, 2019
Slide 1: A Specialty Pharmaceutical Company: Corporate Presentation December 2019
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation December 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 ▪ 36 commercial products ▪ 107 pipeline products (92 previously approved) with total annual market size = $4.3B Branded Drugs ▪ 11 commercial products ▪ 2 pipeline products previously approved with total annual market size = $1.0B Contract Development & Manuf. ▪ 18 c
Slide 4: Senior Management Team
Senior Management Team 4 Name Role Industry Experience Joined ANI Previous Affiliation Arthur Przybyl President and CEO 25 + years 2009 Stephen Carey VP, Finance and CFO 20+ 2016 Robert Schrepfer SVP, BD and Specialty Sales 15+ 2013 James Marken SVP, Operations & Prod. Development 20+ 2007 David Sul
Slide 5: Financial Highlights - 3Q and YTD 2019
Financial Highlights - 3Q and YTD 2019 As compared with prior year: Net revenues increased 10% YTD Adjusted non - GAAP EBITDA increased 6% YTD Adjusted non - GAAP diluted earnings per share increased 6% YTD (1) See Appendix A for US GAAP reconciliations 5 ($ in millions, except per share data) 2019
Slide 6: Third Quarter and YTD 2019 Revenues
Third Quarter and YTD 2019 Revenues Year - to - date results include: Generic sales increased primarily due to the launch of four products during 2019 as well as continued strength in certain 2018 launch products. Brand sales increased primarily due to 2018 launches of Atacand ® , Atacand HCT ® , Ca
Slide 7: 2019 Guidance
2019 Guidance Forecast results assumes: Continued investment in our Cortrophin ® Gel re - commercialization program. The above guidance range includes approximately $18.0 million to $18.5 million of total ANI Research and Development expense as compared to $15.4 million incurred in 2018 Continued se
Slide 8: Commercial Products Revenue & Adjusted non-GAAP EBITDA Growth
$56 $76 $129 $177 $202 $211 ** $27 $43 $61 $74 $84 $86 ** 10 16 25 31 42 47* 0 5 10 15 20 25 30 35 40 45 $0 $30 $60 $90 $120 $150 $180 $210 $240 $270 2014 2015 2016 2017 2018 2019 Guidance Net Revenues Adjusted non-GAAP EBITDA Commercial Products Revenue & Adjusted non - GAAP EBITDA Growth 8 ($ in m
Slide 9: Balance Sheet: Strong Capital Position
Balance Sheet: Strong Capital Position 9 $59.7 million of cash as of September 30, 2019, up 39% from year end ▪ YTD cash flow from operations of $40.8 million and free cash flow of $35.9 million ▪ $21.2 million utilized to acquire ANDA related intangible assets, product rights, and IPR&D Net leverag
Slide 10: Generic Rx - $99.5M Net Sales YTD
Generic Rx - $99.5M Net Sales YTD Strong market share position – top 10 products average approximately 43% share as of September 30, 2019 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 -
Slide 11: Generic Rx – Key New Product Launch: Vancomycin Oral Solution
11 Generic Rx – Key New Product Launch Vancomycin Oral Solution 250mg/5ml ▪ Launched September 2019 ▪ ANI sells the only FDA approved generic product ▪ Convenient pre - flavored single bottle format ▪ Launch supported by broad marketing/awareness program ▪ Annual U.S. vancomycin market exceeds $450M
Slide 12: Generic Rx – Key New Product Launch: Bretylium Tosylate Injection
12 Generic Rx – Key New Product Launch Bretylium Tosylate Injection, 500mg/10ml ▪ ANI’s launch re - introduces this critical care drug to the U.S. market ▪ ANI will support launch with educational programs and broad awareness campaign ▪ 180,000 crash carts in U.S. with recommendation for two vials p
Slide 13: Generic Rx – Pipeline
13 Generic Rx – Pipeline Generic pipeline includes 107 products ▪ At least 53 can be re - commercialized via CBE - 30 or Prior Approval Supplement ▪ Approved ANDAs allow ANI to rapidly respond to changing market dynamics Growing injectable pipeline of five products with total annual market size of $
Slide 14: Brand Rx - $48.3M Net Sales YTD
Brand Rx - $48.3M Net Sales YTD 14 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 15: Brand Rx – Pipeline
15 Brand Rx – Pipeline (1) Based on Company estimates and IQVIA data Total annual market size: $1.0 billion (1) Brand pipeline includes two products: ▪ Cortrophin ® Gel and Cortrophin - Zinc ® ▪ Both are FDA approved and can be re - commercialized via sNDA filing Key Pipeline Product Cortrophin ® Ge
Slide 16: Cortrophin Gel Re-commercialization Milestones
Cortrophin ® Gel Re - commercialization Milestones 16 Manufacture Commercial Scale API 5X scale up to commercial scale Finalize API manufacturing process and initiate process validation Method development for API characterization methods Method validation for API release / stability methods Viral cl
Slide 17: Contract Manufacturing - $8.5M Net Sales YTD
Contract Manufacturing - $8.5M Net Sales YTD 17 Experienced contract manufacturer since 2007 ▪ Quality focus at our three North American manufacturing facilities ▪ Broad scientific and regulatory expertise ▪ Solid oral, liquids, topicals, potent compounds, DEA schedule 2 products ▪ Launched ANI Glob
Slide 18: Baudette Manufacturing Facilities Overview
Main Street Facility – 130K ft 2 IDC Road Facility – 47K ft 2 Overview ▪ 57,000 ft 2 of manufacturing, packaging, and warehouse ▪ Recently completed 5,500 ft 2 warehouse expansion includes additional schedule CII vault & CIII cage space ▪ 17,000 ft 2 of laboratory space for product development and a
Slide 19: Manufacturing Overview – Oakville, Ontario
Canadian Facility – 101K ft 2 Overview ▪ 101,000 ft 2 of manufacturing, packaging, lab, warehouse, and administrative space ▪ US FDA and Health Canada inspected ▪ Controlled drugs and substance license Capabilities ▪ Rx solutions, suspensions, topicals, tablets, and capsules ▪ Serialization - ready
Slide 20: Other Revenue Generating Assets
Other Revenue Generating Assets 20 Yescarta ® Royalty ▪ Originates from assets acquired in BioSante transaction ▪ Entitled to percentage of global Yescarta ® net sales and certain milestones ▪ In June 2018 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a pos
Slide 21: Summary
Summary ANI is an integrated specialty generic pharmaceutical company with: ▪ Profitable base business with substantial pipeline opportunities ▪ Strong capital position ▪ Experienced management team ▪ North American based manufacturing assets and expertise ANI is focused on delivering value through:
Slide 22: Appendix A
22 Appendix A
Slide 23: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 23 2019 2018 2019 2018 Net Income 3,895$ 5,037$ 10,929$ 10,064$ Add back Interest expense, net 3,336 3,768 10,096 11,132 Other expense/(income), net 33 (20) 117 71 (Provision)/Benefit for income taxes 64 1,329 (120) 2,647 Depreciation and amortization 9,473 8,548 35,048 25,
Slide 24: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 24 2019 2018 2019 2018 Net Income 3,895$ 5,037$ 10,929$ 10,064$ Add back Non-cash interest expense 1,871 1,980 5,525 5,839 Depreciation and amortization expense 9,473 8,548 35,048 25,056 Cortrophin pre-launch charges 195 - 195 - Expensed FDA approval milestone payment 329 -
Slide 25: U.S. GAAP Reconciliations: Non-GAAP Measures in 2019 Guidance
U.S. GAAP Reconciliations 25 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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