Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (March 2018)
32 slides from Ani Pharmaceuticals's investor presentation, Mar 7, 2018
Slide 1: Corporate Presentation
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Corporate Presentation March 7, 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 ▪ 24 commercial products ▪ 70 pipeline products; 40 previously approved ▪ Addressable market of pipeline = $1.7B Branded Drugs ▪ 11 commercial products ▪ 4 pipeline products previously approved ▪ Addressable market of pipeline = $1.4B 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 - 4Q and Full Year 2017
Financial Highlights - 4Q and Full Year 2017 Posted record annual Net Revenue, Adjusted non - GAAP EBITDA and Adjusted non - GAAP EPS Net revenues increased 24% from prior year in 4Q and 37% on a full year basis Adjusted non - GAAP EBITDA increased 10% from prior year in 4Q and 21% on a full year ba
Slide 6: Strong Capital Position
Strong Capital Position 6 $31.1 million of cash as of December 31, 2017 ▪ 2017 cash flow from operations of $39.4 million ▪ 2017 free cash flow of $29.0 million Net leverage of 2.0x based upon mid - point of 2018 guidance New $125 million senior secured credit facility includes undrawn $50 million r
Slide 7: Financial Highlights - 2017 Net Revenues
Financial Highlights - 2017 Net Revenues Generic sales gains driven by 2017 and annualization of 2016 launches Brand sales gains reflect the late February 2017 introduction of InnoPran XL ® and Inderal ® XL as well as increased sales of Inderal ® LA which launched in Q2 2016 Contract manufacturing r
Slide 8: 2018 Guidance
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 and 2018 generic launches In
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 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 12: Brand Rx AstraZeneca Transaction
Brand Rx AstraZeneca Transaction 12 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 13: Brand Rx InnoPran XL and Inderal XL
Brand Rx InnoPran XL ® and Inderal ® XL 13 Two additional hypertension brands acquired in first quarter 2017: Purchased on February 23, 2017, for approximately $51 million Generated combined sales of $23.3 million in 2016 according to IMS Health data (gross sales basis) Second quarter of 2017 was fi
Slide 14: 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 ▪ Total full year 2017 Brand Rx net revenues of $50.9 million, up 93% vs.
Slide 15: Contract Manufacturing and Other
Contract Manufacturing and Other 15 Contract manufacturing ▪ $5.5 million of 2016 and $7.0 million of 2017 net revenues ▪ Four customers – Seven products and seventeen SKUs – Contract manufacturing and contract packaging Contract services and other ▪ $1.4 million of 2016 and $0.4 million of 2017 net
Slide 16: Business and Product Development Overview
16 Business and Product Development Overview
Slide 17: Business Development Activity – Generic Products
Business Development Activity – Generic Products 17 NOTES DATE ANI MANUF APPROVED COST ($M) G e n e r i c s Commercial May-16 P P 1% and 2.5% HC Cream to date, 1 product commercialized Aug-15 $0.0 Rowasa® AG (Partnership with Meda) Commercial Jan-16 P $10.0 Lipofen® AG & P P $1.0 IDT Partnership (18
Slide 18: Business Development Activity – Brand Products
Business Development Activity – Brand Products 18 NOTES DATE ANI MANUF APPROVED COST ($M) Total $255.5 $12.0 P P $46.5 Atacand®, Atacand HCT®, Casodex®, Arimidex® (candesartan cilexetil, candesartan cilexetil- hydrochlorothiazide, anastrozole, bicalutamide) Capsules Commercial Inj & Solution in Pipe
Slide 19: Product Development Pipeline
19 Product Development Pipeline Generic Product Pipeline 70 products – 40 can be re - commercialized via CBE30 or Prior Approval Supplement Addressable market of pipeline = $1.7B (1) Brand Product Pipeline 4 products – Cortrophin ® Gel, Cortrophin - Zinc®, Vancocin ® Oral Solution, and Brethine ® ta
Slide 20: 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) 20 Value Creation Provides pati
Slide 21: Cortrophin - Path to Re-Commercialization
Cortrophin ® - Path to Re - Commercialization 21 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 22: Key Re-commercialization Milestones
Key Re - commercialization Milestones 22 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 23: Manufacturing Overview
23 Manufacturing Overview
Slide 24: Main Street 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 25: Main Street Facility
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 26: IDC Road Facility
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 27: 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 28: 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 $228 m
Slide 29: Appendix A
29 Appendix A
Slide 30: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 30 2017 2016 2017 2016 Net (Loss)/Income (9,629)$ (1,080)$ (1,076)$ 3,934$ Add back Interest expense, net 3,026 2,859 12,035 11,327 Other income/(expense), net 3 43 (55) 74 Provision/(benefit) for income taxes 13,979 (524) 17,425 4,744 Depreciation and amortization 7,022 5,
Slide 31: U.S. GAAP Reconciliations
U.S. GAAP Reconciliations 31 2017 2016 2017 2016 Net (Loss)/Income (9,629)$ (1,080)$ (1,076)$ 3,934$ Add back Excess of fair value over cost of acquired inventory 2,946 2,758 10,448 5,938 Non-cash interest expense 1,758 1,784 7,113 7,048 Stock-based compensation 1,422 1,380 6,090 6,067 Depreciation
Slide 32: U.S. GAAP Reconciliations - 2018 Guidance
U.S. GAAP Reconciliations 32 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
ANI Pharmaceuticals — Investor Presentation (March 2018) on 6ix