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Jason Grenfell-Gardner | President and CEO Jenniffer Collins | Chief Financial Officer NASDAQ Global Select: TLGT Teligent, Inc. March 2016

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Page 1: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

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

NASDAQ Global Select: TLGT

Teligent, Inc.

March 2016

Page 2: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Safe Harbor Statement

Except for historical facts, the statements in this presentation, as well as oral statementsor other written statements made or to be made by Teligent, Inc., are forward-lookingstatements within the meaning of the Private Securities Litigation Reform Act of 1995 andinvolve risks and uncertainties. For example, without limitation, statements about theCompany’s anticipated growth and future operations, the current or expected market sizefor its products, the success of current or future product offerings and the research anddevelopment efforts and the Company’s ability to file for and obtain U.S. Food and DrugAdministration (FDA) approvals for future products, are forward-looking statements.

Forward-looking statements are merely the Company’s current predictions of futureevents. The statements are inherently uncertain, and actual results could differ materiallyfrom the statements made herein. There is no assurance that the Company will achievethe sales levels that will make its operations profitable or that FDA filings and approvalswill be completed and obtained as anticipated. For a description of additional risks anduncertainties, please refer to the Company’s filings with the Securities and ExchangeCommission, including its latest Annual Report on Form 10–K and its latest QuarterlyReport on Form 10-Q. The Company assumes no obligation to update its forward-lookingstatements to reflect new information and developments.

2

Page 3: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Teligent Overview

Listed on NASDAQ Global Select as of 10/26/15 Symbol - TLGT

FDA Registered Manufacturing 23,000 Sq Ft Facility Buena, NJ

Stock Price (3/11/16) || 52-Week Range $4.93 || $4.53 – $9.18

Fully Diluted Shares Outstanding, as converted (12/31/2015) 67 million

Convertible debt of $143.75 million (12/31/2015) $143.75 million

Cash (12/31/2015), Raised $138 million, net of costs in Convertible Debt offering in 12/14 $87.2 million

Revenue 2014, 2015 $33.7 million, $44.5 million

Full-time Employees 116

Fiscal Year December 31st

Accounting Firm EisnerAmper, LLP

3

Page 4: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Investment Highlights

4

Specialty Generics Targeting Attractive Markets

• Fully-integrated specialty generics pharmaceutical company• Pursuing Topical, Injectable, Complex and Ophthalmic markets

Growing Development Pipeline

• 31 ANDAs on file with $1.4 bn Total Addressable Market1. • 15 ANDAs filed in 2015

Diversified Product Portfolio

• 13 Teligent products (topical and injectable) in 35 presentations• Received first GDUFA Year Three ANDA approval for Desoximetasone Ointment

in Feb 2016• Acquired the assets of Canadian company Alveda Pharmaceuticals, Inc,

including 19 injectable products in 34 presentations in Nov 2015

High-quality Manufacturing

• 23,000 sq ft FDA-approved, cGMP-compliant facility • Flexible and broad capabilities, with a significant expansion underway

Proven, Dynamic Management Team

• Experienced team with a track record of delivering• Culture founded on Impactful Science, Quality and Craftsmanship

1. Source: IMS Health, January 2016

Page 5: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Our Management Team

5

Jason Grenfell-GardnerPresident & 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 CollinsCFO

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

Steve RichardsonCSO

• Steve brings almost 30 years of experience in Regulatory and R&D efforts, including experience with Lachman Consultants, Inc., JHP Pharmaceuticals and Stiefel Laboratories.

Page 6: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Our Management Team

6

Michael BethellGeneral Manager, Canada

• Michael has more than 20 of supply chain, operations and marketing experience. Prior to Teligent, 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 SimmGeneral Manager, Estonia

• 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 LawrenceSVP, Technical Services

• Nadya has served in various roles at Teligent for more than 20 years, including Operations VP. She leads technical transfers and manages our contract manufacturing business.

Fred WeissVP, Quality

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

Sanjay SamudreOperations Director

• Sanjay has 20 years of experience in pharmaceutical operations, including Mediatech, Inc., a Corning Subsidiary, Qualitest Pharmaceuticals and Ciba Vision sterile, a Novartis company.

Peter GallagherVP, Strategic Affairs

• 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.

Page 7: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Our Foundation for Growth

Our Vision is to become a leading specialized generics company with a diversified portfolio.

7

We are transforming our business model to a science-driven specialty generics platform.

• Submits 4 ANDAs for FDA approval

• Enters into supply agreement with NeoStrata

• Enters long-term strategic partnership with Medimetriks

• Appoints JennifferCollins 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 vs. ’13)

• Submits 15 ANDAs for FDA approval

• Acquires Alveda Pharmaceuticals in Canada

• Developing first 505(b)(2) project

• Launches 3 injectable products

• Receives approval for Cefotan

• Submits 9 ANDAs for FDA approval

• Appoints Jason Grenfell-Gardner as CEO

• Acquires EconazoleNitrate

• Launches IGI Label portfolio of AGs

• Grows net sales by 112% (’13 vs. ’12)

2012-2013 2014 2015

Page 8: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Building Our Topical R&D Track Record

8

In 2015, we have submitted 15 ANDAs.

Our R&D investment is coupled with significant top-line growth and a culture of Quality.

2010 2011 2012 2013 2014 2015

Net sales ($m) $6.1 $7.8 $8.6 $18.2 $33.7 $44.5

Headcount 36 36 42 54 81 116Source: Company data

2 48

1319

312

3

2010A 2011A 2012A 2013A 2014A 2015A

Cumulative filings Cumulative approvals

Page 9: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Now, Broadening Our Portfolio

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

We have established a highly-productive development platform:• 31 topical ANDAs under FDA review

with a TAM of $1.4 billion1

Expanding Our CapabilitiesBuilding from Our Roots

91. Source: IMS Health, January 2016, TAM – Total Addressable Market

9

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

Topicalgenerics

TopicalInjectableComplex

Ophthalmic

Science-driven generics portfolio

Page 10: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

1

• The addressable US topical market is $12.5bn, 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

TICO: Topical Market

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 January 2016

US Generic Topical Landscape2US Topical Market

Sales

10

Branded22%

Branded Generic

24%

Generic45%

Other9%

$0

$200

$400

$600

$800

$1,000

$1,200

Sand

oz

Taro

Perri

go

Akor

n

Myl

an

Acta

vis

(US$

m)

Page 11: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Topical: Cornerstone of Expertise

11

Attractive Market• $5.7bn US generic market, growing faster than 19% over three years, driven

by price• Historical strength and expertise for Teligent

Broad Scope of Organic R&D Opportunities

• Teligent to file ANDAs for all commercially reasonable AT-rated products and AB-rated corticosteroids (approximately 39 more) by late 2016/early 2017

• Development program to expand to products requiring Phase III clinical studies

• Developing first 505(b)(2) project in the DESI to NDA pathway

Contract-to-TeligentLabel Transition

• Strategic focus and P&L shifted to Teligent label products, but retain steady cash flow from contract services

• Shift to revenue from pharmaceutical partners continues, as pharma was 91% of contract services revenue in Q4 2015

Page 12: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Our 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 January 2016, with no 483 observations

• Capacity utilization is approximately 70% based on compounding one to two 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 our needs into 2017

• Recently acquired the adjacent 10,500 sq ft building for administrative offices and our future R&D lab

• R&D/product development lab renovations started in Q1 2016, with move-in planned for mid-year 2016

12

Page 13: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Significant Site Expansion Increase topical production capacity, install sterile manufacturing suite

• Scope:

• Expand the number of topical compounding rooms and packaging lines, including the installation of a high-speed bottle filler and construction of a compounding room for alcohol-based products

• Expand lab capacity for Quality Control and R&D, increase and consolidate warehouse space

• Build a new sterile injectable suite with an isolator-based fill line for vials and ampules

• Status:

• R&D Lab demolition and renovations began in February 2016

• Detailed design is underway; long lead-time isolator and filling lines have been ordered

13

Artist’s rendering of the Teligent complex in 2017

Page 14: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

TICO: Injectable Market

Source: IMS Health, MAT January 2016; Wall Street research

• 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

US Injectable MarketUS Generic Injectable LandscapeSales Units

14

Brand80%

Branded Generic

13%

Generic7% Brand

25%

Branded Generic

26%

Generic49%

$0$200$400$600$800

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

Hos

pira

Fres

eniu

s

Sand

oz

Myl

an

Wes

tWar

d

Dr R

eddy

's

Grif

ols

Baxt

er

Sage

nt

Teva

Sun

Win

thro

p

Akor

n

Reg

ent

Acta

vis

Intl

Med

Padd

ock

Acco

rd

B. B

raun

Auro

med

ics

Apot

ex

Line

age

X-G

en

WG

Crit

ical

Her

itage(1

2 m

onth

IMS

(US

$m)

Page 15: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Injectable: Sizable Opportunities

15

Attractive Market

• The $8.2bn generic injectable market continues to struggle with drug shortages and regulatory challenges

• 46 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 Teligent

• Opportunistic strategy to identify and pursue single-source products, fragile supply chain, and/or drug shortage

• Sold the first Teligent injectable products in October 2015• Expanding North American footprint with acquisition of assets of Alveda

Pharmaceuticals in Canada which closed in November 2015

Page 16: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Injectable & Ophthalmic Progress

16

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 6 development/supply agreements, with others under review with CRO/CMOs

Expand In-house Development Team

• 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

Design and Build In-house Manufacturing Capability

• In-house manufacturing capability strengthens our ownership of the Quality Systems, improves margins, and builds internal expertise

• Township Planning & Zoning Board has approved the project• The detailed design master plan is in process, and long-lead time equipment

orders have been placed

Page 17: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Pipeline Is Well-Positioned for New GDUFA Landscape

17

15 ANDAs were filed in 2015

Sources: 1. IMS Health, MAT January 2016; Company dataDoes not include submissions filed with partners.

# of ANDA Filings % of Total Addressable Marketof ANDAs on File

1813

02468

101214161820

GDUFA Year 3 &Year 4

Prior to GDUFA Year3

26%

74%

Prior to GDUFA Year 3GDUFA Year 3 & Year 4

Page 18: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Growing, Increasingly Diverse Pipeline

Delivery/Therapy Area FocusCommercial/Regulatory Status

18

Teligent Label Product and Pipeline Mix: Total of 105 products US & 27 Canada

Source: Company data

Currently marketed products

13Currently marketed products -Canada

19

Previously approved products

22

Filed with the FDA31

Filed with Health Canada

4

Pipeline - on stability, 10

Pipeline 29

Pipeline-Canada - 4

9

31

10

29

419

2

2

19

4 4

0

5

10

15

20

25

30

35

Currentlymarketedproducts

PreviouslyApprovedProducts

On file Pipeline -on stability

Pipeline

Num

ber o

f pro

duct

s

Topical Injectable Ophthalmic

Page 19: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Teligent Canada – Alveda Pharma Update

19

• Transaction closed November 13th, 2015• 19 molecules, 34 injectable products• Established in the Canadian institutional marketplace• Market leader in most products

• Established new Corporate Structure to include offices in Canada and Estonia

• Granted expedited review by Health Canada for new submission

• Pipeline of 8 injectable products, 4 of which are under review by Health Canada.

• We plan to file 8 ANDSs in Canada in 2016.

Page 20: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Financial Highlights – 2016 Guidance

20

``

- 10 20 30 40 50 60 70 80

2014 2015 2016 Guidance

Mill

ions

Revenue by Business Line

44%

46%

48%

50%

52%

54%

56%

2014 2015 2016 Guidance

Gross Margin

-

1

2

3

4

5

6

7

8

2014 2015 2016 Guidance

Mill

ions

Adjusted EBITDA• We intend to submit at least 15 ANDAs with the FDA , additional 8 ANDSs in 2016. • To complete all of the development work required for the 2016 filings, we expect to spend between 28% and 32% of total revenue on R&D by the end of 2016.• The Company expects operating income between $1.0 and $2.0 million for the year ended December 31, 2016.

Page 21: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market

Teligent

Closing

21

Specialty Generics Targeting Attractive Markets

• Fully-integrated specialty generics pharmaceutical company• Pursuing Topical, Injectable, Complex and Ophthalmic markets

Growing Development Pipeline

• 31 ANDAs on file with $1.4 bn Total Addressable Market1. • 15 ANDAs filed 2015

Diversified Product Portfolio

• 13 Teligent products (topical and injectable) in 35 presentations• Strategy to diversify our product mix and customer base• Acquired the assets of Canadian company Alveda Pharmaceuticals, Inc,

including 19 injectable products in 34 presentations in Nov ’15

High-quality Manufacturing

• 23,000 sq ft FDA-approved, cGMP-compliant facility • Flexible and broad capabilities, with a significant expansion underway

Proven, Dynamic Management Team

• Experienced team with a track record of delivering• Culture founded on Impactful Science, Quality and Craftsmanship

1. Source: IMS Health, January 2016

Page 22: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market
Page 23: Jason Grenfell-Gardner | President and CEO ... · NASDAQ Global Select: TLGT Teligent, Inc. March 2016. Teligent Safe Harbor Statement ... •The $8.2bn generic injectable market