Jason Grenfell-Gardner | President and CEO Jenniffer Collins | Chief Financial Officer NASDAQ Global Select: TLGT Teligent, Inc. January 2016
Jason Grenfell-Gardner | President and CEO Jenniffer Collins | Chief Financial Officer NASDAQ Global Select: TLGT
Teligent, Inc.
January 2016
Teligent
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 Teligent, 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.
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Teligent
Investment Highlights
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Specialty Generics Targeting Attractive Markets
• Fully-integrated specialty generics pharmaceutical company • Pursuing Topical, Injectable, Complex and Ophthalmic markets
Growing Development Pipeline
• 33 ANDAs on file with $1.7 bn Total Addressable Market1. • 15 ANDAs filed in 2015
Diversified Product Portfolio
• 10 Teligent products (topical and injectable) in 29 presentations • Strategy to diversify our product mix and customer base • Acquired the assets of Canadian company Alveda Pharmaceuticals, Inc,
including 17 injectable products in 36 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 Science, Quality and Craftsmanship
1. Source: IMS Health, November 2015
Teligent
Our Management Team
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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.
Nadya Lawrence SVP, 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 Weiss VP, Quality
• Fred has over 25 years of experience in pharmaceutical quality, including from Medicia, Schering-Plough and Carter Wallace.
Sanjay Samudre Operations 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 Gallagher VP, 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.
Teligent
Our Foundation for Growth
Our Vision is to become a leading specialized generics company with a diversified portfolio.
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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 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 vs. ’13)
• Submits 15 ANDAs for FDA approval
• Initiates CMO development and supply for injectable and ophthalmic pipeline
• Developing first 505(b)(2) project
• Launches 3 injectable products
• 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 vs. ’12)
2012-2013 2014 2015
Teligent
Building Our Topical R&D Track Record
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In 2015, we have submitted 15 ANDAs. .
2 approvals
2 8 13 22
2010A 2011A 2012A 2013A 2014A
Cumulative filings Cumulative approvals
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Our R&D investment is coupled with significant top-line growth and a culture of Quality.
2010 2011 2012 2013 2014
Net sales ($m) $6.1 $7.8 $8.6 $18.2 $33.7
Headcount 36 36 42 54 81 Source: Company data
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:
• 33 topical ANDAs under FDA review with a TAM of $1.7 billion1
Expanding Our Capabilities Building from Our Roots
7 1. Source: IMS Health, November 2015, TAM – Total Addressable Market
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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
Topical generics
Topical Injectable Complex
Ophthalmic
Science-driven generics portfolio
Teligent
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• The addressable US topical market is $12.2bn, of which generics make up $5.9bn; 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, 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 November 2015
US Generic Topical Landscape2 US Topical Market
Sales
8
$0
$200
$400
$600
$800
$1,000
$1,200
San
doz
Taro
Per
rigo
Ako
rn
Myl
an
Act
avis
12
mon
th IM
S ($
m)
Branded 21%
Branded Generic
22% Generic
48%
Other 9%
Teligent
Topical: Cornerstone of Expertise
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Attractive Market • $5.9bn 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 33 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-Teligent Label 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 Q3 2015
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 December 2013, with 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 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 are starting in Q1 2016, with move-in planned for mid-year 2016
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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:
• Project approval by the Township Planning & Zoning Board
• Detailed design is underway; long lead-time isolator and filling lines have been ordered
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Artist’s rendering of the Teligent complex in 2017
Teligent
$0$200$400$600$800
$1,000$1,200$1,400$1,600$1,800
Hospira
Fresen
ius
Sand
oz
WestW
ard
DrRed
dy's
Mylan
Baxter
Grifo
ls
Sagent
Winthrop
Sun
Teva
Actavis
Akorn
Regent
IntlMed
Apotex
Accord
B.Braun
Padd
ock
Auromed
ics
X-Ge
n
Line
age
Heritage
WGCriScal
12m
onthIM
S($m)
Brand 80%
Branded Generic
13%
Generic 7% Brand
25%
Branded Generic
26%
Generic 49%
TICO: Injectable Market
Source: IMS Health, MAT November 2015; 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 Market US Generic Injectable Landscape Sales Units
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Teligent
Injectable: Sizable Opportunities
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Attractive Market
• The $8.0bn generic injectable market continues to struggle with drug shortages and regulatory challenges
• 47 molecules for injection/infusion are currently on the FDA drug shortage list, with more reported by ASHP
Compelling Dynamics
• Existing market participants focus R&D efforts on newly genericized products and assume that shortages will be resolved by existing players as regulatory issues are remediated
• We challenge this assumption and see an upside opportunity
Unique Opportunity for Teligent
• Opportunistic strategy to identify and pursue single-source products, fragile supply chain, and/or drug shortage
• Sold the first Teligent injectable products in October 2015 • Expanding North American footprint with acquisition of assets of Alveda
Pharmaceuticals in Canada which closed in November 2015 • Received approval of Cefotan® in December 2015 (first AZ/VRX products)
Teligent
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TICO: Ophthalmic Market
n The generic ophthalmic landscape is currently limited, with 2 players holding 72% of sales (61% of units) n Growth is driven by an aging population and an increased awareness of eye health n The existing combination of older products and blockbusters creates a portfolio of development
opportunities through product acquisition and organic R&D
. 1. Includes OTC, private label and veterinary products Source: IMS Health, MAT November 2015; Wall Street research
US Generic Ophthalmic Landscape US Ophthalmic Market Sales
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Brand 47%
Branded Generic
29%
Generic 16%
Other 8%
0
100
200
300
400
500
600
Sand
oz
Valeant
Pacific
Akorn
Perrigo
Greenstone
Lupin
Par
Other
12m
onthIM
S($m)
Teligent
Ophthalmic: Leverage Our Infrastructure
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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 our market entry
Unique Opportunity for Teligent
• Ophthalmics will effectively leverage our R&D, Regulatory, Quality and Commercial infrastructure
• Products will add to our portfolio diversification with wholesalers/GPOs • First product launch targeted for 2016
Teligent
Injectable & Ophthalmic Progress
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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 have approved the project • The detailed design master plan is in process, and long-lead time equipment
orders have been placed
Teligent
Pipeline Is Well-Positioned for New GDUFA Landscape
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15 ANDAs were filed in 2015
Sources: 1. IMS Health, MAT November 2015; Company data Does not include submissions filed with partners.
# of ANDA Filings % of Total Addressable Market of ANDAs on File
40%
60%
Prior to GDUFA Year 3 GDUFA Year 3 & Year 4
19 14
0 2 4 6 8
10 12 14 16 18 20
GDUFA Year 3 & Year 4
Prior to GDUFA Year 3
Num
ber o
f fili
ngs
Teligent
Growing, Increasingly Diverse Pipeline
Delivery/Therapy Area Focus Commercial/Regulatory Status
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Teligent Label Product and Pipeline Mix: Total of 101 products US & 25 Canada
Source: Company data
Currently marketed products
10
Previously approved products
23
Filed with the FDA 33
Filed with Health
Canada 4
Currently Marketed -
Canada 17
[CATEGORY NAME]
[VALUE]
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[VALUE]
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[VALUE]
7
33
14
19 3
20
2 2
17
4
4
0
5
10
15
20
25
30
35
Currently marketed products
Previously Approved Products
On file Pipeline - on stability
Pipeline
Num
ber o
f pro
duct
s
Topical Injectable Ophthalmic Complex Suppository Canada
Teligent
Teligent Canada – Alveda Pharma
Transaction Summary > Acquisition of the assets of Alveda Pharmaceuticals, Inc. closed on November 13, 2015 > Accretive transaction provides Teligent a platform to expand its specialty generic pharmaceutical
portfolio of products across Canada > As part of the closing, we formed three subsidiaries: Teligent Luxembourg S.à.r.l., Teligent OÜ, a
private limited company incorporated under the laws of Estonia, and Teligent Canada, Inc. > Acquisition was pursuant to two asset purchase agreements:
• Acquisition of intellectual property-related assets by Teligent OÜ • Acquisition of all other assets by Teligent Canada, Inc.
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Alveda Summary > Net sales of approximately $16m CAD for fiscal year ended September 30, 2015 > Pipeline:
• 8 injectable products, 4 of which are under review by Health Canada > Portfolio:
• 17 molecules (36 injectable presentations) in the Canadian market • We believe that Alveda is the market leader in Canada for most of the products in the company’s
catalogue
Teligent
Closing
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Specialty Generics Targeting Attractive Markets
• Fully-integrated specialty generics pharmaceutical company • Pursuing Topical, Injectable, Complex and Ophthalmic markets
Growing Development Pipeline
• 33 ANDAs on file with $1.7 bn Total Addressable Market1. • 15 ANDAs filed 2015
Diversified Product Portfolio
• 10 Teligent products (topical and injectable) in 29 presentations • Strategy to diversify our product mix and customer base • Acquired the assets of Canadian company Alveda Pharmaceuticals, Inc,
including 17 injectable products in 36 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 Science, Quality and Craftsmanship
1. Source: IMS Health, November 2015