August Teligent, Inc. Jason Grenfell-Gardner CEO Jenniffer Collins CFO. NASDAQ Global Select: TLGT

Transcription

1 August 2016, Inc. Jason Grenfell-Gardner CEO Jenniffer Collins CFO NASDAQ Global Select: TLGT

2 Safe Harbor Statement Except for historical facts, the statements in this presentation, as well as oral statements or other written statements made or to be made by, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. For example, without limitation, statements about the Company s anticipated growth and future operations, the current or expected market size for its products, the success of current or future product offerings and the research and development efforts and the Company s ability to file for and obtain U.S. Food and Drug Administration (FDA) approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company s current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that FDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks and uncertainties, please refer to the Company s filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10 K and its latest Quarterly Report on Form 10-Q. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. 2

3 Investment Highlights Specialty Generics Targeting Attractive Markets Growing Development Pipeline Diversified Product Portfolio High-quality Manufacturing Fully-integrated specialty generics pharmaceutical company Pursuing Topical, Injectable, Complex and Ophthalmic markets 33 ANDAs on file in US with $1.6 bn Total Addressable Market 1, 5 BM1 Applications on file in Canada Target of 8 ANDSs submitted to Health Canada in 2016 Target of 15 ANDAs submitted to FDA in total for 2016, 5 filed YTD products (topical and injectable) in 40 presentations in the US Received first GDUFA Year Three ANDA approval for Desoximetasone Ointment in Feb 2016, launched 2Q 2016 Acquired the assets of Canadian company Alveda Pharmaceuticals Inc, including 18 injectable products in 38 presentations in Nov 2015 FDA-approved, cgmp-compliant facility, No 483 observations in the last three inspections, recently inspected in January 2016 Flexible and broad capabilities, with a significant expansion underway to expand and automate topical manufacturing and add sterile manufacturing capabilities Proven, Dynamic Management Team Experienced team with a track record of delivering Culture founded on Impactful Science, Quality and Craftsmanship 1. Source: IMS Health, June

4 Slide 3 BM1 Confirm 5 on file in Canada Brian Maxwell, 8/1/2016

5 Our Management Team Jason Grenfell-Gardner President & CEO Jason brings significant experience in generic sales and marketing, supply chain, and management from his time at West-Ward Pharmaceuticals and Hikma Pharmaceuticals. MBA from INSEAD. Jenniffer Collins CFO Jenniffer has over 20 years of experience in finance and accounting including experience at several public companies and PWC. Steve Richardson CSO Steve brings almost 30 years of experience in Regulatory and R&D efforts, including experience with Lachman Consultants, Inc., JHP Pharmaceuticals and Stiefel Laboratories. 4

6 Our Management Team Michael Bethell General Manager, Canada Anneli Simm General Manager, Estonia Nadya Lawrence SVP, Technical Services Fred Weiss VP, Quality Peter Gallagher VP, Strategic Affairs Eric Muse VP, Business Development Michael has more than 20 of supply chain, operations and marketing experience. Prior to, he worked with Terminal Systems Inc., Bioniche Life Sciences Inc., and Alveda Pharmaceuticals Inc., where he served as COO. Michael holds a Bachelor s of Business Administration degree from Acadia University. Anneli has over 15 years of experience in management consulting, financial advisory, investor relations and M&A. Anneli has worked at KPMG Estonia, Deloitte, the Estonian Energy Company and Trigon Capital, among other firms. She graduated from Concordia International University with a BA in international business. Nadya has served in various roles at for more than 20 years, including Operations VP. She leads technical transfers and manages our contract manufacturing business. Fred has over 25 years of experience in pharmaceutical quality, including from Medicia, Schering-Plough and Carter Wallace. Peter has over 15 years of strategic planning, operational and corporate affairs experience at Bausch + Lomb in Brazil, Merck, Schering-Plough and the US Navy. MBA from NYU Stern. Eric has over 15 years of business development, strategy and investment management experience at Akorn, Baxter International and Citadel, among other firms. He holds a Master s degree in Biotechnology from Northwestern University. 5

7 Our Foundation for Growth Our Vision is to become a leading specialized generics company with a diversified portfolio Submits 13 ANDAs for FDA approval Appoints Jason Grenfell-Gardner as CEO Appoints Jenniffer Collins as CFO Acquires Econazole Nitrate Launches IGI Label portfolio of AGs Grows net sales by 112% ( 13 vs. 12) Receives first 2 ANDA approvals Submits 11 ANDAs for FDA approval Launches TICO strategy for portfolio diversification Initiates planning for two 505(b)(2) opportunities Grows net sales by 85% ( 14 vs. 13) Submits 15 ANDAs for FDA approval Acquires and launches 3 US Injectable Products Acquires Alveda Pharma in Canada Developing first 505(b)(2) project Receives FDA approval for Cefotan 2016 Submits 5 ANDAs for FDA approval, plan to submit up to 15 Plans to file 8 ANDSs in Canada Receives first cycle GDUFA year three ANDA approval Working on first generic orphan drug project We are transforming our business model to a science-driven specialty generics platform. 6

8 Building Our R&D Track Record In 2015, we submitted 15 ANDAs to FDA. So far in 2016, we have submitted 5 ANDAs, with a target to submit a total of 15 ANDAs to FDA in A 2011A 2012A 2013A 2014A 2015A 2016 Cumulative filings Cumulative approvals Net sales ($m) $6.1 $7.8 $8.6 $18.2 $33.7 $44.5 $ R&D Spend ($m) $1.5 $2.2 $2.8 $2.8 $6.9 $ % 1 Headcount Source: Company data 1: Based on revenue guidance for fiscal year 2016, 2: As of July

9 We Continue to Diversify Our Portfolio Building from Our Roots Topical generics Expanding Our Capabilities Topical Injectable Complex Ophthalmic Science-driven generics portfolio We have established a highlyproductive development platform: 33 topical ANDAs under FDA review with a TAM of $1.6 billion 1 Our expansion is underway to deliver a diversified portfolio through TICO: Topicals: Cornerstone of our expertise Injectables: Favorable market opportunities Complex: Unique product/regulatory situations Ophthalmics: Leverage our infrastructure Expanding our development and commercial focus to TICO generics leverages our proven expertise so that we can deliver a broader product mix to the market 1. Source: IMS Health, June 2016, TAM Total Addressable Market 8

10 Our Transformation Is Driven By Diversification and Growth Diversification of Commercial Portfolio 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2Q Q 2016 Topical Injectable Complex Opthalmic # of Products in North American Portfolio Q Q 2016 US Canada 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Transition To Prescription Products 2Q Q 2016 Prescription Costmetic OTC Regulatory Applications On File 2Q Q 2016 ANDAs with FDA Applications with Health Canada 9

11 TICO: Topical Market US Topical Market US Generic Topical Landscape 2 1 Other 8% Sales Branded 23% (US$m) $1,000 $800 $600 $400 $200 Generic 43% Branded Generic 26% $0 Sandoz Taro Perrigo Akorn Global Pharm Actavis The addressable US topical market is $13.1bn, of which generics make up $5.7bn; the generic space has grown rapidly, with a 3-year CAGR of 19%, while volumes have decreased by 2% The market has 6 major players who control about 65% of the script volume, with significant barriers to entry Consolidation continues, e.g., Sandoz/Fougera, Watson/Actavis and Akorn/Hi-Tech, Actavis/Teva The presence of small players creates a degree of market fragmentation 1. Includes OTC and any products that have not been assigned a Brand/Generic value because not enough information is available, (b) Excludes companies with less than 5% of market sales. 2. Source: IMS Health, MAT June

12 Topical: Cornerstone of Expertise Attractive Market $5.7bn US generic market, growing faster than 16% over three years, driven by price Historical strength and expertise for Broad Scope of Organic R&D Opportunities to file ANDAs for all commercially reasonable AT-rated products and AB-rated corticosteroids (approximately 24 more) by 2017 Development program to expand to products requiring Phase III clinical studies Contract-to- Label Transition Strategic focus and P&L shifted to label products, but retain steady cash flow from contract services Shift to revenue from pharmaceutical partners continues, as pharma was 92% of contract services revenue in 2Q 2016, compared to 75% in 2Q

13 Expansion Underway to Increase R&D and Production Capacity and Capabilities Site Overview 33,500 sq ft campus, including an FDA-approved facility to make pharmaceuticals and medical devices Capability to develop and produce creams, ointments, lotions, gels, solutions and suspensions Most recent FDA inspection in January 2016, with no 483 observations Capacity utilization is approximately 75% based on compounding 1-2 products/day and filling one/day Based on current forecasts, capacity constraints begin in 2017 Expansion Supports TICO Growth Strategy New high-speed tube-filling line is now on-line for commercial production Product Development lab renovations started in Q1 2016, with move-in on-target for mid-year 2016 Planning phase of manufacturing facility expansion to be completed in 2Q16 and break ground on facility expansion, estimated $45-$50 million to complete by end of

14 Where We Are Going 13 13

15 Phasing of Renovation and Construction Phase 1: 1Q16/2Q16 R&D Lab and administrative office renovation On Track Phase 2: 2Q16 Break ground on topical Manufacturing facility renovation and expansion Phase 4: 2Q17 Transition to New Compounding Suite and Packaging Renovation Phase 3: 1-2Q17 Build out of sterile injectable manufacturing suite 14

16 TICO: Injectable Market US Generic Injectable Landscape US Injectable Market Sales Units Branded Generic 12% Generic 7% Brand 25% (12 month IMS (US$m) $1,800 $1,600 $1,400 $1,200 $1,000 $800 $600 $400 $200 $0 Brand 81% Generic 49% Branded Generic 26% Hospira Fresenius Sandoz Mylan Grifols WestWard Dr Reddy's Winthrop Teva Sagent Baxter Akorn Regent Sun Intl Med Actavis Auromedics Paddock Accord The market for generic injectables offers attractive opportunities (7% CAGR expected by 2016) High barriers to entry given required sterile manufacturing and increased regulatory scrutiny by FDA Industry continues to see consolidation, due in part to scarcity value of products (e.g., Pfizer/Hospira) Difficult formulations result in fewer future entrants, better price consistency and longer life cycles Sales channel focused on reliability and consistency of supply, and not always price-driven Source: IMS Health, MAT June 2016; Wall Street research 15

17 Building Out TICO : Progress Beyond Topicals Product/Acquisition Action Acquisition of 3 US Injectables Fortaz, Zinacef, and Zantac October 2015 Acquisition of Alveda Pharma 18 injectable products November 2015 Previously approved product 1 (Cefotan for Injection) Approved Dec 2015, Launched Mar 2016 Previously approved product 2 Previously approved product 3 Previously approved product 4 Generic Orphan Drug New ANDA, target filing 4Q16 PAS target filing 1Q17 PAS target filing 1Q17 ANDA target filing 1Q17 Expand In-house Development Team Design and Build In-house Manufacturing Capability With 3 rd -party manufacturing capacity available, emphasis shifts to expanding our development and analytical team for in-house formulation Goal is to establish a robust cycle of in-house lab-to-cmo transfers during the next year, in order to accelerate growth of our commercial portfolio In-house manufacturing capability strengthens our ownership of the Quality Systems, improves margins, and builds internal expertise The detailed design master plan is being finalized, new R&D lab is complete, and long-lead time equipment expected to arrive in early

18 Pipeline Is Well-Positioned for New GDUFA Landscape 15 ANDAs were filed in 2015, 5 ANDAs were filed YTD # of ANDA Filings % of Total Addressable Market of ANDAs on File % 21% 0 GDUFA Year 3 & Year 4 Prior to GDUFA Year 3 Prior to GDUFA Year 3 GDUFA Year 3 & Year 4 Sources: 1. IMS Health, MAT June 2016; Company data Does not include submissions filed with partners. 17

19 Growing, Increasingly Diverse Pipeline Label Product and Pipeline Mix: Total of 105 products US & 30 Canada Commercial/Regulatory Status 40 Delivery/Therapy Area Focus Pipeline 25 Pipeline - on stability, 6 Filed with Health Canada 5 Filed with the FDA 33 Pipleine - Canada, 7 Currently marketed products 16 Currently marketed products - Canada 18 Previously approved products 22 Number of products Currently marketed products 2 19 Previously Approved Products 5 33 On file 6 Pipeline - on stability Pipeline Topical Injectable Ophthalmic Complex Suppository Canada Source: Company data 18

20 Financial Highlights 2016 Guidance Revenue Gross Margin $ m `` Guidance 70% 60% 50% 40% 30% 20% 10% 0% Guidance We intend to submit at least 15 ANDAs with the FDA, and 8 Applications in Canada in Adjusted EBITDA We expect to spend between 28% and 32% of total revenue on R&D by the end of `` $ m We expect operating income between $1.0 and $2.0 million for the year ended Dec 31, Guidance 19

21 Closing Specialty Generics Targeting Attractive Markets Fully-integrated specialty generics pharmaceutical company Pursuing Topical, Injectable, Complex and Ophthalmic markets Growing Development Pipeline Diversified Product Portfolio High-quality Manufacturing 33 ANDAs on file in US with $1.6 bn Total Addressable Market 1, 5 Applications on file in Canada Target of 8 ANDSs submitted to Health Canada in 2016 Target of 15 ANDAs submitted to FDA in total for 2016, 3 filed in 1Q16 16 products (topical and injectable) in 40 presentations in the US Received first GDUFA Year Three ANDA approval for Desoximetasone Ointment in Feb 2016, launched 2Q 2016 Acquired the assets of Canadian company Alveda Pharmaceuticals Inc, including 18 injectable products in 38 presentations in Nov 2015 FDA-approved, cgmp-compliant facility, No 483 observations in the last three inspections, recently inspected in January 2016 Flexible and broad capabilities, with a significant expansion underway to expand and automate topical manufacturing and add sterile manufacturing capabilities Proven, Dynamic Management Team Experienced team with a track record of delivering Culture founded on Impactful Science, Quality and Craftsmanship 1. Source: IMS Health, June

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