Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (May 2018)
33 slides from Ani Pharmaceuticals's investor presentation, May 16, 2018
Slide 1: Corporate Presentation May 2018
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation May 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 ▪ 27 commercial products ▪ 72 pipeline products; 50 previously approved ▪ Addressable market of pipeline = $3.4B Branded Drugs ▪ 11 commercial products ▪ 4 pipeline products previously approved ▪ Addressable market of pipeline = $1.2B CMO / Manufacturing ▪ 4 CMO clie
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 - 1Q 2018
Financial Highlights - 1Q 2018 Posted record quarterly Adjusted non - GAAP EBITDA and Adjusted non - GAAP EPS Net revenues increased 27% from prior year Adjusted non - GAAP EBITDA increased 48% from prior year Adjusted non - GAAP diluted earnings per share increased 78% from prior year (1) See Appen
Slide 6: Strong Capital Position
Strong Capital Position 6 $52.0 million of cash as of March 31, 2018, up 67% from year end ▪ 1Q 2018 cash flow from operations of $22.9 million and free cash flow of $20.6 million Net leverage of 1.75x based upon mid - point of 2018 guidance $125 million senior secured credit facility includes undra
Slide 7: Financial Highlights – 1Q 2018 Net Revenues
Financial Highlights – 1Q 2018 Net Revenues Brand sales reflect the February 2018 re - launch of InnoPran XL ® and Inderal ® XL in the ANI label as well as increased sales of Inderal ® LA which launched in Q2 2016 Royalty and other income includes $5.4 million of royalty associated with our December
Slide 8: 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 ® Maximizing the potential of our currently commercialized product portfolio, 2018 generic lau
Slide 9: Growth Led by New Product Introductions
$30 $56 $76 $129 $177 $220 ** $8 $27 $43 $61 $74 $95 ** 7 10 16 25 31 0 5 10 15 20 25 30 35 $0 $30 $60 $90 $120 $150 $180 $210 $240 2013 2014 2015 2016 2017 2018 Net Revenues Adjusted EBITDA Commercial Products * Growth Led by New Product Introductions 9 ($’s in millions) * 2017 products do not incl
Slide 10: Sales and Marketing Overview
10 Sales and Marketing Overview
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 produc
Slide 12: Generic Rx Product Portfolio
Propranolol ER Capsules (AG) Generic Rx Product Portfolio 2016 & 2017 Product Introductions Diphenoxylate HCL and Atropine Sulfate Erythromycin Ethylsuccinate Fenofibrate Capsules (AG) HC Cream, for rectal use Indapamide Lithium Carbonate ER (AG) Mesalamine Enema (AG) Nilutamide Tablets Oxycodone Ca
Slide 13: Brand Rx AstraZeneca Transaction
Brand Rx AstraZeneca Transaction 13 Acquired the NDAs and U.S. rights to four brands including two hypertension and two hormone based chemotherapy drugs Purchased on December 29, 2017, for approximately $46.5 million Generated combined sales of $19.0 million in U.S. gross market sales during the tra
Slide 14: Brand Rx InnoPran XL and Inderal XL
Brand Rx InnoPran XL ® and Inderal ® XL 14 Two additional hypertension brands acquired in first quarter 2017: Purchased on February 23, 2017, for approximately $51 million Second quarter of 2017 was first full quarter of sales and gross profit contribution
Slide 15: 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 ▪ Number of branded product families has grown through acquisitions from f
Slide 16: Contract Manufacturing and Other
Contract Manufacturing and Other 16 Contract manufacturing ▪ $7.0 million of full year 2017 and $0.9 of first quarter 2018 net revenues ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Royalty and other ▪ $0.4 million of full year 2017 and $5.7 mil
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 Total to date, 3 products re- commercialized Jan-14 P P $12.5 ANDA Basket 1 $59.1 Nimodipine Commercial Omega in pipeline Aug-13 and Apr-14 $1.1 (22 previously approved ANDAs) $4.5 Flecainide (flecainide tablets) (31 previously approved ANDAs) Nimo
Slide 19: Business Development Activity – Brand Products
Business Development Activity – Brand Products 19 NOTES DATE ANI MANUF APPROVED COST ($M) Total $255.5 $12.0 P P Casodex® & Arimidex® (bicalutamide & anastrozole) Capsules Commercial Inj & Solution in Pipeline Aug-14 P $11.0 Vancocin® Assets $0.0 Brethine® (terbutaline tablets ) Commercial Apr-16 P
Slide 20: Product Development Pipeline
20 Product Development Pipeline Generic Product Pipeline 72 products – 50 can be re - commercialized via CBE30 or Prior Approval Supplement Addressable market of pipeline = $3.4B (1) Brand Product Pipeline 4 products – Cortrophin ® Gel, Cortrophin - Zinc®, Vancocin ® Oral Solution, and Brethine ® ta
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 pati
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 ma
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 Select drug product CMO 6 mos. Complete • Drug prod
Slide 24: Manufacturing Overview
24 Manufacturing Overview
Slide 25: Main Street and IDC Road 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 26: Main Street Facility Solid Dose Manufacturing
Main Street Facility Solid Dose Manufacturing ▪ Particle Size Control – Sieving, Oscillating Granulators, Fitzmills , Comils ▪ Blending / Granulating – Wet and Dry capability – Marion Paddle Mixers, V - Blender, Gemco Slant Cone – Collette Gral 600 High Shear Granulator (100 – 200kg) – Collette Gral
Slide 27: IDC Road Facility Solid Dose Manufacturing
IDC Road Facility Solid Dose Manufacturing ▪ Particle Size Control – Sieving, Oscillating Granulators, Fitzmills , Comils – Alpine Pin Mill (1Q18) ▪ Blending / Granulating – Wet and Dry capability – Marion Paddle Mixers, V - Blender, Gemco Cone Blenders – Gemco Formulator (jacketed) – Collette Gral
Slide 28: Recently Expanded Warehouse Capacity
Recently Expanded Warehouse Capacity Pallet Spaces Main Street Facility Approved Rack Spaces 1,471 Quarantine Rack Spaces 136 Reject Spaces 14 CIII (Cage Spaces) 180 CII (Vault Spaces) 116 Containment Facility Approved Rack Spaces 216 Building 5 (Bulk Materials / Equipment Storage) Approved Rack Spa
Slide 29: 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 ▪ 2018 Annual guidance (1) – Net revenues of $212 million to $228 m
Slide 30: Appendix A
30 Appendix A
Slide 31: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 31 2018 2017 Net Income 2,250$ 1,152$ Add back Interest expense, net 3,634 2,932 Other expense, net 61 18 Provision for income taxes 592 523 Depreciation and amortization 8,195 6,706 Add back Stock-based compensation 1,377 1,386 Excess of fair value over cost of acquired in
Slide 32: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 32 2018 2017 Net Income 2,250$ 1,152$ Add back Excess of fair value over cost of acquired inventory 5,645 1,535 Non-cash interest expense 1,914 1,792 Stock-based compensation 1,377 1,386 Depreciation and amortization expense 8,195 6,706 Expenses related to transaction not c
Slide 33: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 33 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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