jason grenfell-gardner | president and ceo ... · nasdaq global select: tlgt teligent, inc. march...
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Jason Grenfell-Gardner | President and CEOJenniffer Collins | Chief Financial Officer
NASDAQ Global Select: TLGT
Teligent, Inc.
March 2016
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.
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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
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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
• 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
Teligent
Our Management Team
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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.
Teligent
Our Management Team
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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.
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 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
Teligent
Building Our Topical R&D Track Record
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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
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
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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
Topicalgenerics
TopicalInjectableComplex
Ophthalmic
Science-driven generics portfolio
Teligent
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• 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
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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)
Teligent
Topical: Cornerstone of Expertise
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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
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
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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:
• R&D Lab demolition and renovations began in February 2016
• 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
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
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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)
Teligent
Injectable: Sizable Opportunities
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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
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 has 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 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
Teligent
Growing, Increasingly Diverse Pipeline
Delivery/Therapy Area FocusCommercial/Regulatory Status
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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
Teligent
Teligent Canada – Alveda Pharma Update
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• 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.
Teligent
Financial Highlights – 2016 Guidance
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``
- 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.
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
• 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