Annual Meeting of Stockholders

Transcription

1 Annual Meeting of Stockholders May 20, 2015 Jason Grenfell-Gardner President and CEO Jenniffer Collins Chief Financial Officer NYSE MKT: IG

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 IGI Laboratories, 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 Our Board of Directors James C. Gale Director and Chairman Narendra N. Borkar Director John Celentano Director Bhaskar Chaudhuri Director Jason Grenfell-Gardner Director Steven Koehler Director Member: Organization and Compensation Committee, Nominating and Corporate Governance Committee Member: Organization and Compensation Committee Member: Organization and Compensation Committee, Audit Committee Member: Audit Committee, Nominating and Corporate Governance Committee President and Chief Executive Officer Member: Audit Committee 3

4 Our Team Jason Grenfell-Gardner CEO Jenniffer Collins CFO Nadya Lawrence SVP Contract Services Fred Weiss VP Quality Sanjay Samudre Director of Operations Peter Gallagher VP Strategic Affairs 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 has over 20 years of experience in finance and accounting including experience at several public companies and PWC. Nadya has been with IGI for over 20 years in a number of roles including VP of Operations, and now leads all technical transfers. Fred has over 25 years of experience in pharmaceutical quality, including from Medicia, Schering-Plough, and Carter Wallace. Sanjay has 20 years of experience in pharmaceutical operations, including Mediatech Inc., a Corning Subsidiary, Qualitest Pharmaceuticals, and at Ciba Vision sterile, a Novartis company. 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 New York University. Thomas Vandervort IGI has an experienced management team capable of delivering results VP Business Development Thomas has over 10 years of experience in business development, including experience with Centric Health Resources and West-Ward Pharmaceuticals. 4

5 IGI Overview Listed on NYSE MKT FDA Registered Manufacturing 23K Sq Ft Facility Symbol - IG Buena, NJ Stock Price (5/19/15) 52-Week Range $5.70 $4.45 $12.05 Fully Diluted Shares Outstanding, as converted, including convertible debt (3/31/15) Debt, including convertible debt of $ million (3/31/15) Cash (3/31/15), Raised $138 million, net of costs in Convertible Debt offering in 12/14 Revenue 2013, million $147.0 million $158.0 million $18.2 million, $33.7 million Full-time Employees 87 Fiscal Year Accounting Firm December 31 st EisnerAmper, LLP 5

6 Investment Highlights Specialty Generics Targeting Attractive Markets Growing Development Pipeline Unique fully-integrated specialty generics pharmaceutical company pursuing new TICO Generics strategy Topical, Injectable, Complex and Ophthalmic markets have increasing opportunities which are highly desirable and growing, often characterized by limited competition and/or drug shortages 24 ANDAs currently on file including 11 filed in 2014, 2 in 2015 and we plan to file 18 more in 2015 Recently acquired 23 previously marketed products 20 injectable and 2 ophthalmic to launch broader generics strategy and more diversified commercial portfolio Re-invigorated development team, targeting more involved bioequivalence and selected 505(b)(2) opportunities to move higher up the value chain Tentative approval of Diclofenac sodium topical solution 1.5% in May 2014 (expect Q launch) Validated IGI Commercialization Platform High-quality Manufacturing 2014 Net Sales = $33.7m, 98% CAGR ( ) Currently market seven IGI Label products in 12 presentations 23,000 sq ft FDA-approved, cgmp-compliant facility with clean FDA inspection record Flexible and broad capabilities include creams, ointments, lotions, gels, solutions and suspensions Contract services turn-key manufacturing business focused on prescription topical products Proven, Dynamic Management Team Experienced specialty pharmaceuticals team with a strong track record of high-growth performance Focused organization committed to Quality, Craftsmanship and Execution 6

7 Laying Our Foundation Our Vision is to become a leading Specialized Generics Company with a diversified portfolio Submits 4 ANDAs for FDA approval Enters into supply agreement with NeoStrata Enters long-term strategic partnership with Medimetriks Appoints Jenniffer Collins as CFO Submits 9 ANDAs for FDA approval Appoints Jason Grenfell-Gardner as CEO Acquires Econazole nitrate Launches IGI Label portfolio of AGs Grows net sales by 112% ( 13/ 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/ 13) Submits 2 ANDAs for FDA approval, with goal to submit total of 20 in 2015 Initiates CMO development and supply for injectable and ophthalmic pipeline Will hold first IND meeting on 505(b)(2) project IGI is transforming its business model from a focus on contract manufacturing to a value-added, science-driven specialty generics platform. 7

8 Building Our Topical R&D Track Record So far in 2015, we have submitted 2 ANDAs, and are on track for 18 more ANDAs by December. Cumulative filings Cumulative approvals 2 approvals A 2011A 2012A 2013A 2014A Our R&D engine is coupled with significant top-line growth and a culture of Quality and Execution. Revenue $6.1 $7.8 $8.6 $18.2 $33.7 People Note: ANDA filing and approval figures exclude partnered products Source: Company data 8

9 Now, Broadening Our Portfolio Building from Our Roots Expanding Our Capabilities Topical Generics Topical + Injectable Complex Ophthalmic Science-driven Generics Portfolio IGI has established a compelling, high-productivity development platform, focused on execution to deliver a diversified portfolio: 24 ANDAs under FDA review with a TAM of $747 million Our expansion is underway into the TICO Generic space, ensuring a broad, diversified portfolio: Topicals: Cornerstone of our expertise Injectables: Favorable market opportunities Complex: Unique product/regulatory situations Ophthalmics: High leverage of our infrastructure Expanding our development and commercial focus to TICO Generics will leverage existing expertise, and deliver a broader product mix to the market. 9 (a). Source: IMS Health, March 2015

10 Market #1: Topicals US Topical Market US Generic Topical Landscape (b) Sales $1,000 Other 11% (a) Branded 20% (US$m) $800 $600 $400 $200 Generic 48% Branded Generic 21% $0 Taro Perrigo Sandoz Akorn Mylan Actavis The addressable US topical market is $11.0bn, of which generics make up $5.3bn; 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 60% of the script volume, with significant barriers to entry Consolidation continues, e.g., Sandoz/Fougera, Watson/Actavis and Akorn/Hi-Tech (TBD on Mylan/Perrigo) The presence of small players creates a degree of market fragmentation (a) 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. (b) Source: IMS Health, MAT Mar

11 Topicals: Cornerstone of Expertise Attractive Market $5.3bn US generic market, growing faster than 19% - driven by price Historical strength and expertise for IGI Broad Scope of Organic R&D Opportunities IGI to file ANDAs for all commercially reasonable AT-rated products and AB-rated corticosteroids (approximately 42 more) by the end of 2016 Development program to expand to products requiring Phase III clinical studies Initiated two 505(b)(2) projects in the DESI to NDA pathway Contract to Rx Label Transition Strategic focus and P&L shifted to IGI label products, but retain steady cash flow from contract services Shift to revenue from pharmaceutical partners continues, as pharma was 79% of contract services revenue in Q and FY 2014, compared to 71% in Q

12 IGI Topical Center of Excellence 23,000 sq ft FDA-approved facility to manufacture pharmaceutical products and medical devices Capability to develop and produce creams, ointments, lotions, gels, solutions and suspensions Most recent inspection in December 2013 no 483 observations Capacity utilization is approximately 70% based on compounding one product per day and filing one product per day Based on current forecasts, with modest capital expenditures, capacity at the existing facility would be sufficient for IGI s needs into 2017 R&D lab expansion completed in June

13 Expansion for Future Capacity As the number of approved ANDAs increases, we will need additional production and lab capacity to meet market demand Design work is currently underway to expand the number of compounding rooms, packaging lines, labs and warehouse space Unique capabilities such as highalcohol compounding and topical foams are under consideration The expansion will capitalize on our established infrastructure and development expertise 13

14 Market #2: Injectables $m US Generic Injectable Landscape $1,600 $1,400 $1,200 $1,000 $800 $600 $400 $200 $0 Hospira Fresenius Sandoz WestWard Baxter Dr Reddy's Grifols Mylan Winthrop Sun Sagent Actavis Branded Generic 11% Brand 82% Greenstone Apotex Sales Generic 7% Teva US Injectable Market Regent Akorn Intl Med Branded Generic 26% B. Braun Brand 27% Auromedics Accord Units Heritage X-Gen Paddock Generic 47% Lineage The market for generic injectables is vibrant (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 Mar 2015; Wall Street research 14

15 Injectables: Sizable Opportunities Attractive Market The $8.5bn generic injectable market continues to struggle with drug shortages and regulatory challenges 53 molecules for injection/infusion are currently on the FDA drug shortage list, with more reported by ASHP Compelling Dynamics Existing market participants focus R&D efforts on newly genericized products and assume that shortages will be resolved by existing players as regulatory issues are remediated We challenge this assumption and see an upside opportunity Unique Opportunity for IGI Our development and quality infrastructure driven by our robust commitment to Quality can be carefully leveraged to build an organic pipeline of overlooked, high-value injectable products 15

16 Market #3: Ophthalmics US Ophthalmic Market US Generic Ophthalmic Landscape Generic 18% Other 8% Sales (a) Brand 46% (12 month IMS (US$m) Branded Generic 28% Sandoz Valeant Pacific Akorn Lupin Perrigo Greenstone Par Other The generic ophthalmic landscape is currently limited, with two players holding 71% of sales (64% of units) Growth is driven by an aging population and an increased awareness of eye health The existing combination of older products and blockbusters creates a portfolio of development opportunities through product acquisition and organic R&D (a) Includes OTC, private label and veterinary products Source: IMS Health, MAT Mar 2015; Wall Street research 16

17 Ophthalmics: Leverage Infrastructure Attractive Market We believe the $1.3bn US generic ophthalmic market is similar to the generic topical market that existed in 2010 There is limited competition due to market consolidation Compelling Dynamics Existing market participants focus R&D efforts on newly genericized products Degree of industry consolidation and balance between branded vs. generic markets creates an attractive environment for IGI market entry Unique Opportunity for IGI Ophthalmics will effectively leverage future IGI plant capacity and internal infrastructure Products will add to our portfolio diversification with wholesalers/gpos 17

18 Injectable & Ophthalmic Progress Access CMO Network Initial driver is speed to market for priority products, by partnering with high-quality contract manufacturers who support our cost structure We have signed 5 development/supply agreements, with others under review with CRO/CMOs Expand In-house Development Talent 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 Design & Build In-house Fill Capacity In-house manufacturing capability strengthens our ownership of the Quality Systems, improves margins, and builds internal expertise The design master plan is under review, and equipment vendors have submitted proposals 18

19 Continued Increase in R&D Productivity 14 So far in 2015, we are seeing faster response times from the FDA for GDUFA Year 3 Filings 12 Number of filings Filed 1 5 Approved < 1 year 1-2 years 2-3 years > 3 years Source: Company data 19

20 FDA Increasing Pace of Response We are receiving and processing more requests GDUFA Performance Goal for Year 3: 60% of ANDAs reviewed in 15 months 7 ANDAs submitted 8 ANDAs submitted 1 Approval 1 Tentative Approval 4 Complete Response Letters 2 accepted for filing - 1 Information Request 11 ANDAs submitted 1 Complete Response Letter 5 accepted for filing - 1 labeling request 5 no responses 5 accepted for filing - 4 Information Requests - 1 labeling request 1 Filing Review Comments (pre-acceptance) 1 no response Sept 2010 Dec 2012 (Paper filing) Jan 2013 Sept 2014 (Electronic, pre-gdufa Yr 3) Oct 2014 Today (Electronic, GDUFA Yr 3)

21 Growing, Increasingly Diverse Pipeline IGI Label Product & Pipeline Mix Commercial/Regulatory Status Delivery/Therapy Area Focus Currently marketed products 7 (a) Pipeline 30 Previously approved products 23 Number of products Topical Injectable Ophthalmic Complex 14 Pipeline - on stability 14 Filed with the FDA Currently marketed products Approved products On file Pipeline - on stability Pipeline Suppository Total number of products: 98 (a) Includes Diclofenac sodium which is approved and will launch in Spring 2015 Source: Company data 21

22 Closing Specialty Generics Targeting Attractive Markets Unique fully-integrated specialty generics pharmaceutical company Pursuing the Topical, Injectable, Complex and Ophthalmic markets Growing Development Pipeline 24 ANDAs currently on file with a plan to file 18 more in (b)(2) opportunities taking shape to deliver higher-value products Validated IGI Commercialization Platform Seven IGI Label products in 12 presentations Strategy to diversify the product mix, and customer base High-quality Manufacturing 23,000 sq ft FDA-approved, cgmp-compliant facility Flexible and broad capabilities, with expansion plan underway Proven, Dynamic Management Team Experienced team with a strong track record of delivering Culture founded on Quality, Craftsmanship and Execution 22

23 The IGI Team 2015 Day of Service Buena, New Jersey Nearly 80 employees participated in the packaging of 22,000 units of Econazole Nitrate antifungal product that was donated to AmeriCares. 23