Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Investor Presentation (June 2017)
20 slides from Ani Pharmaceuticals's investor presentation, Jun 19, 2017
Slide 1: A Specialty Pharmaceutical Company
A Specialty Pharmaceutical Company NASDAQ: ANIP GENERIC AND BRANDED PRESCRIPTION DRUG PRODUCTS Investor Presentation June 20, 2017
Slide 2: Forward-Looking Statements
2 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, stat
Slide 3: Experienced Senior Management Team
3 Experienced Senior Management Team 3 With ANI Since Previous Affiliation Arthur S Przybyl President and CEO 2009 Akorn Stephen Carey VP, Finance and CFO 2016 Par Pharmaceutical James Marken SVP, Operations & Prod. Development 2007 Solvay Robert Schrepfer SVP, BD and Specialty Sales 2013 Healthcare
Slide 4: Building a Stable Base with Diversified Growth
4 Building a Stable Base with Diversified Growth What we do: Acquire, develop, manufacture and commercialize GENERIC Rx products Acquire, manufacture and commercialize MATURE BRAND Rx products Provide high quality CONTRACT MANUFACTURING services to select clients Our strategy: Assemble a portfolio o
Slide 5: Three Platforms Form Strong Base Business
5 Three Platforms Form Strong Base Business 5 Generic Rx Brand Rx CMO Company estimates, IMS Health - March 2017 • 22 commercial products • 1Q17 net revenues: $26.6M (+101% vs. 1Q16) • 74 Pipeline products – 43 previously approved and can be re - commercialized via CBE30 or Prior Approval Supplement
Slide 6: Commercial Products Growth Led by New Product Introductions
6 $30 $56 $76 $129 $8 $27 $43 $61 7 10 16 25 29 0 5 10 15 20 25 30 $0 $30 $60 $90 $120 $150 $180 $210 2013 2014 2015 2016 2017 Net Revenues Adjusted EBITDA Commercial Products Growth Led by New Product Introductions 6 ($s millions) Net Revenues $181 - $190 Adj. EBITDA $73.1 - $77.2 * * 29 Commercial
Slide 7: Transformational Acquisition: Cortrophin Assets
7 Transformational Acquisition: Cortrophin Assets 7 Jan. 2016 - ANI Acquires Two NDAs from Merck for $75 Million + % Net Sales • NDA #008975 Purified Cortrophin Gel, 40 units/mL and 80 units/mL • NDA #009854 Cortrophin - Zinc, 40 units/mL • Drug Master File 4181 for corticotropin (withdrawn) • API P
Slide 8: Cortrophin - A Compelling Strategic Opportunity
8 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) 8 Value Creation Provides Patie
Slide 9: Cortrophin - Path to Re-Commercialization
9 Cortrophin - Path to Re - Commercialization 9 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 man
Slide 10: Uniquely Experienced Team Assembled
10 Uniquely Experienced Team Assembled 10 Build Dedicated ANI Team Cortrophin Analytics Team • Director of Cortrophin Analytics – 25 years experience in large molecule analytics, biochemistry and bioinformatics • Direct experience developing and modernizing analytical methods for API and drug produc
Slide 11: Partner Secured for Pituitary Source
11 Partner Secured for Pituitary Source 11 Source Pig Pituitary Supply Secured commercial scale quantities of pig pituitary glands from a leading pork producer in the U.S. Supplier has multiple U.S. - based sites that can meet ANI’s requirements Supplier is currently harvesting porcine glands for ot
Slide 12: Modernize API Manufacturing Process & Analytics
12 Modernize API Manufacturing Process & Analytics 12 Manufacture API Reproduce/Modernize Historical API Manufacturing Process Manufacturing Process ▪ Reduce process from “paper” to practice with minimal process changes ▪ Modernize process / equipment for compliance and quality ▪ Comprehensive under
Slide 13: Modernize API Manufacturing Process & Analytics: Small-Scale Batch
13 Modernize API Manufacturing Process & Analytics 13 Manufacture API Reproduce/Modernize Historical API Manufacturing Process First Small - scale API Successfully Manufactured ▪ Objective: familiarize with each step of the API manufacturing process ▪ Weight yield assessed after completion of each p
Slide 14: Commercial-Scale Corticotropin API Manufacturing
14 Modernize API Manufacturing Process & Analytics 14 Manufacture API Reproduce/Modernize Historical API Manufacturing Process Commercial - scale Corticotropin API Manufacturing ▪ Objective: increase scale of API manufacturing process by ~ 5x from intermediate - scale ▪ Manufacture batch to demonstr
Slide 15: Modernize Analytics
15 Modernize API Manufacturing Process & Analytics 15 Manufacture API Modernize Analytics Historical Analytical Methods: ▪ Out - dated and not compliant with current FDA standards ▪ Only employed at end of API manufacturing process Objectives: Update/Modernize existing analytical methods ▪ Analytica
Slide 16: Secure Drug Product Manufacturer
16 Secure Drug Product Manufacturer 16 Manufacture Drug Product Ideal Contract Manufacturer RFP issued to select U.S. based drug product CMOs Strong history manufacturing sterile injectable products & FDA compliance Experience manufacturing API from animal tissues Appropriate scale to manufacture pr
Slide 17: Regulatory Strategy for Re-commercialization
17 Regulatory Strategy for Re - commercialization 17 Finalize Regulatory Strategy Comparability protocol ▪ Goal: Demonstrate comparability to previously marketed product ▪ Retrospective comparison to historical data package including in - process, characterization, release and stability data Fully m
Slide 18: Final Corticotropin Label Subject to FDA Discussions
18 Final Corticotropin Label Subject to FDA Discussions H.P. Acthar® Label - H.P. Acthar ® Gel is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection Corticotropin Label(s) - Cortrophin G
Slide 19: Key Re-commercialization Milestones
19 Key Re - commercialization Milestones 19 Duration Status Additional Details Manufacture small - scale batch of corticotropin API 4 mos. Complete • Initial batch yields equivalent to historical yields • Analytical method development and testing ongoing • Initiate stability testing Select drug prod
Slide 20: Cortrophin - Substantial Commercial Opportunity
20 Cortrophin - Substantial Commercial Opportunity 20 Commercial Opportunity Subject to finalization of: ▪ Product label ▪ ANI pricing strategy ▪ Sales and marketing plan Illustrative example^: Commercial Strategy Provide patients with drug pricing relief Deploy targeted specialty sales force Suppor
ANI Pharmaceuticals — Investor Presentation (June 2017) on 6ix