Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (June 2019)
23 slides from Ani Pharmaceuticals's investor presentation, Jun 12, 2019
Slide 1: Corporate Presentation June 2019
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation June 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 ▪ 33 commercial products ▪ 100 pipeline products; 96 previously approved ▪ Total annual market size = $3.2B Branded Drugs ▪ 11 commercial products ▪ 3 pipeline products previously approved ▪ Total annual market size = $1.1B Contract Development & Manuf. ▪ 19 clients
Slide 4: Senior Management Team
Senior Management Team 4 Name Role Industry Experience Joined ANI Previous Affiliation Arthur Przybyl President and CEO 25 + years 2009 Stephen Carey VP, Finance and CFO 20 2016 Robert Schrepfer SVP, BD and Specialty Sales 15 2013 James Marken SVP, Operations & Prod. Development 20 2007 David Sulliv
Slide 5: First Quarter 2019 Financial Results
First Quarter 2019 Financial Results As compared with prior year: Net revenues increased 14% Adjusted non - GAAP EBITDA increased 2% Adjusted non - GAAP diluted earnings per share decreased 1.5% (1) See Appendix A for US GAAP reconciliations 5 ($ in millions, except per share data) 2019 2018 Net rev
Slide 6: First Quarter 2019 Revenues
First Quarter 2019 Revenues Results include: Generic sales increase primarily due to the launch of Ezetimibe - Simvastatin, Candesartan, and other products launched in 2018, as well as increased unit sales of Vancomycin Brand sales increase primarily due to 2018 launches of Atacand ® , Atacand HCT ®
Slide 7: 2019 Guidance
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 $16.5 million
Slide 8: Commercial Products Revenue & Adjusted EBITDA Growth
$56 $76 $129 $177 $202 $238 ** $27 $43 $61 $74 $84 $100 ** 10 16 25 31 42 44* 0 5 10 15 20 25 30 35 40 45 $0 $30 $60 $90 $120 $150 $180 $210 $240 $270 2014 2015 2016 2017 2018 2019 Guidance Net Revenues Adjusted EBITDA Commercial Products Revenue & Adjusted EBITDA Growth 8 ($’s in millions) * Produc
Slide 9: Balance Sheet: Strong Capital Position
Balance Sheet: Strong Capital Position 9 $38.2 million of cash as of March 31, 2019, down 11% from year end ▪ 1Q cash flow from operations of $14.3 million and free cash flow of $12.5 million ▪ $18.5 million utilized to acquire ANDA related intangible assets in Q1 2019 Net leverage of 1.5x as of Mar
Slide 10: Generic Rx - $31.6M Net Sales for 1Q 2019
Generic Rx - $31.6M Net Sales for 1Q 2019 Strong market share position – top 10 products average approximately 51% share as of March 29, 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
Slide 11: Generic Rx – Pipeline
11 Generic Rx – Pipeline ANDA Pipeline includes 100 products ▪ At least 52 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 (36mg & 54mg) ▪ $563M market Aspir
Slide 12: Brand Rx - $17.5M Net Sales for 1Q 2019
Brand Rx - $17.5M Net Sales for 1Q 2019 12 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 ®
Slide 13: Brand Rx – Pipeline
13 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 Pipelin
Slide 14: Cortrophin Gel Re-commercialization Milestones
Cortrophin ® Gel Re - commercialization Milestones 14 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
Slide 15: Contract Manufacturing - $2.4M Net Sales for Q1 2019
Contract Manufacturing - $2.4M Net Sales for Q1 2019 15 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 annual rev
Slide 16: Main Street Facility and IDC Road Facility 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 17: 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 18: ANI Royalty & Other Income - $1.3M Net Revenues for Q1 2019
ANI Royalty & Other Income - $1.3M Net Revenues for Q1 2019 18 Royalty income primarily reflects: ▪ $0.2 million for sales and milestones on Yescarta ® ▪ $0.5 million related to one - time royalty true - up Yescarta ® Royalty ▪ ANI recognized $0.2 million in royalties and milestones ▪ Originates fro
Slide 19: Summary
Summary ANI is an integrated specialty generic pharmaceutical company with: ▪ Profitable base business generating organic growth ▪ Strong capital position ▪ Experienced management team ▪ North American based manufacturing assets and expertise ANI is focused on delivering value through: ▪ Partnership
Slide 20: Appendix A
20 Appendix A
Slide 21: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 21 2019 2018 Net Income 449$ 2,250$ Add back Interest expense, net 3,354 3,634 Other expense, net 130 61 Provision for income taxes 469 592 Depreciation and amortization 16,103 8,195 Add back Stock-based compensation 1,710 1,377 Excess of fair value over cost of acquired in
Slide 22: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 22 2019 2018 Net Income 449$ 2,250$ Add back Non-cash interest expense 1,799 1,914 Depreciation and amortization expense 16,103 8,195 Stock-based compensation 1,710 1,377 Excess of fair value over cost of acquired inventory - 5,645 Transaction and integration expenses 84 -
Slide 23: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 23 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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