igi laboratories, inc. september 2015 jason grenfell-gardner – president and ceo jenniffer collins...

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IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

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Page 1: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

IGI Laboratories, Inc.

September 2015

Jason Grenfell-Gardner – President and CEOJenniffer Collins – Chief Financial Officer

NYSE MKT: IG

Page 2: IGI Laboratories, Inc. September 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.

Page 3: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

3

IGI Overview

Listed on NYSE MKT Symbol - IG

FDA Registered Manufacturing 23K Sq Ft Facility Buena, NJ

Stock Price (9/11/15) || 52-Week Range $8.65 || $4.75 – $12.05

Fully Diluted Shares Outstanding, as converted (6/30/15) 67 million

Debt, including convertible debt of $143.75 million (6/30/15) $147.0 million

Cash (6/30/15), Raised $138 million, net of costs in Convertible Debt offering in 12/14 $150.0 million

Revenue 2013, 2014 $18.2 million, $33.7 million

Full-time Employees 92

Fiscal Year December 31st

Accounting Firm EisnerAmper, LLP

Page 4: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Investment HighlightsSpecialty Generics

Targeting Attractive Markets

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

Growing Development

Pipeline

29 ANDAs currently on file – including 11 filed in 2014, 7 in 2015 and we plan to file up to 13 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

Approval and launch of Diclofenac sodium topical solution 1.5% in July 2015

Validated IGI Commercialization

Platform

2014 Net Sales = $33.7m, 98% CAGR (2012-2014) Currently market seven IGI Label products in 12 presentations

High-quality Manufacturing

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

4

Page 5: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

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.

Jason Grenfell-GardnerCEO

Jenniffer has over 20 years of experience in finance and accounting including experience at several public companies and PWC.

Jenniffer CollinsCFO

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.

Sanjay SamudreDirector of Operations

Fred has over 25 years of experience in pharmaceutical quality, including from Medicia, Schering-Plough, and Carter Wallace.

Fred WeissVP Quality

IGI has an experienced management team capable of delivering results

Our Team

5

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.

Peter GallagherVP Strategic Affairs

Thomas has over 10 years of experience in business development, including experience with Centric Health Resources and West-Ward Pharmaceuticals.

Thomas VandervortVP Business Development

Nadya has been with IGI for over 20 years in a number of roles including VP of Operations, and now leads all technical transfers.

Nadya LawrenceSVP Contract Services

Page 6: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

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

2010-2011

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 7 ANDAs for FDA approval, with goal to submit up to 20 in 2015

Initiates CMO development and supply for injectable and ophthalmic pipeline

Will hold first IND meeting on 505(b)(2) project

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)

6

IGI is transforming its business model from a focus on contract manufacturing to a value-added, science-driven specialty generics platform.

2012-2013 2014 2015

Page 7: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

So far in 2015, we have submitted 7 ANDAs, and are working on up to 13 more ANDAs by December.

Building Our Topical R&D Track Record

Note: ANDA filing and approval figures exclude partnered productsSource: Company data 7

2 approvals

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 36 36 42 54 81

2

2010A 2011A 2012A 2013A 2014A

8 1322

Cumulative filingsCumulative approvals

4

Page 8: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Now, Broadening Our Portfolio

TopicalGenerics

Topical +

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

IGI has established a compelling, high-productivity development platform, focused on execution to deliver a diversified portfolio:• 29 ANDAs under FDA review with a

TAM of $1.4 billion

Expanding our development and commercial focus to TICO Generics will leverage existing expertise, and deliver a broader product mix to the market.

Expanding Our CapabilitiesBuilding from Our Roots

InjectableComplexOphthalmic

Science-driven Generics Portfolio

8(a). Source: IMS Health, July 2015

Page 9: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

The addressable US topical market is $11.8bn, 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 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

Market #1: Topicals

(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 Jul 2015

US Generic Topical Landscape (b)US Topical Market

9

Sales(a)

Taro

Sand

oz

Perr

igo

Akor

n

Myl

an

Acta

vis

$0

$200

$400

$600

$800

$1,000

(US$

m)

Branded20%

Branded Generic21%

Generic49%

Other10%

Page 10: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Topicals: Cornerstone of Expertise

Attractive Market

$5.7bn 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 75% of contract services revenue in Q2 2015

10

Page 11: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

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 2014

11

Page 12: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

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 high-alcohol compounding and topical foams are under consideration

The expansion will capitalize on our established infrastructure and development expertise

12

Page 13: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Market #2: Injectables

Source: IMS Health, MAT Jul 2015; Wall Street research

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

US Injectable MarketUS Generic Injectable Landscape

13

Sales Units

Hosp

ira

Fres

eniu

s

Sand

oz

Wes

tWar

d

Dr R

eddy

's

Baxt

er

Myl

an

Grifo

ls

Sage

nt

Win

thro

p

Sun

Acta

vis

Teva

Akor

n

Rege

nt

Apot

ex

Intl

Med

Acco

rd

B. B

raun

Padd

ock

Auro

med

ics

X-Ge

n

Herit

age

Linea

ge

WG

Criti

cal

$0$200$400$600$800

$1,000$1,200$1,400$1,600$1,800

(12

mon

th IM

S (U

S$m

)

Brand81%

Branded Generic12%

Generic7%

Brand25%

Branded Generic27%

Generic49%

Page 14: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Injectables: Sizable Opportunities

Attractive Market

• The $7.7bn 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

14

Page 15: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Market #3: Ophthalmics

The generic ophthalmic landscape is currently limited, with two players holding 69% 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 Jul 2015; Wall Street research

US Generic Ophthalmic LandscapeUS Ophthalmic Market

(a)

15

Sales

Brand47%

Branded Generic29%

Generic17%

Other8%

Sand

oz

Vale

ant

Pacifi

c

Akor

n

Perr

igo

Lupi

n

Gree

nsto

ne Par

Oth

er

0

100

200

300

400

500

600

(12

mon

th IM

S (U

S$m

)

Page 16: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Ophthalmics: Leverage Infrastructure

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

Ophthalmics will effectively leverage future IGI plant capacity and internal infrastructure

Products will add to our portfolio diversification with wholesalers/GPOs

Attractive Market

Unique Opportunity

for IGI

16

Page 17: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Injectable & Ophthalmic Progress

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 3rd-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 design master plan is under review, and equipment vendors have submitted proposals

Access CMO Network

Design & Build In-house Fill

Capacity

17

Page 18: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Continued Increase in R&D Productivity

So far in 2015, we are seeing faster response times from the FDA for GDUFA Year 3 Filings

Source: Company dataIncludes partnered FDA submissions 18

< 1 year 1 - 2 years 2 - 3 years > 3 years

0

2

4

6

8

10

12

14

12

10

65

2

Filed Approved

Nu

mb

er

of

filin

gs

Page 19: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Status of Submissions Under ReviewStep-change in FDA Correspondence for GDUFA Year 3 Filings

19

Page 20: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

Growing, Increasingly Diverse Pipeline

IGI Label Product & Pipeline Mix

Total number of products: 98Source: Company data 20

Delivery/Therapy Area FocusCommercial/Regulatory Status

Currently marketed products

Approved products

On file Pipeline - on stability

Pipeline

0

5

10

15

20

25

30

7 7

29

14

25

20

2

2

Topical

Injectable

Ophthalmic

Complex

Suppository

Nu

mb

er

of

pro

du

cts

Currently marketed products

7

Previously ap-proved products

23

Filed with the FDA29

Pipeline - on stability

14

Pipeline 25

Page 21: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

ClosingSpecialty Generics

Targeting Attractive Markets

Unique fully-integrated specialty generics pharmaceutical company Pursuing the Topical, Injectable, Complex and Ophthalmic markets

Growing Development

Pipeline

29 ANDAs currently on file – with a plan to file up to 13 more in 2015 505(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

21

Page 22: IGI Laboratories, Inc. September 2015 Jason Grenfell-Gardner – President and CEO Jenniffer Collins – Chief Financial Officer NYSE MKT: IG

22

The IGI Team

2015 Day of ServiceBuena, New Jersey

Nearly 80 employees participated in the packaging of 22,000 units of Econazole Nitrateantifungal product that was donated to AmeriCares.