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Cowen and Company 37th
Annual Health Care
Conference
March 7, 2017
2
Impax Cautionary Statement Regarding Forward
Looking Statements
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature
and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known
and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from
the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but
are not limited to: fluctuations in revenues and operating income; the Company’s ability to successfully develop and commercialize
pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the
Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the
impact of competition; the Company’s ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection
with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s
operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals;
consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and
quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the
Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the
Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the
Company’s lack of a license partner for commercialization of NUMIENTTM (IPX066) outside of the United States; impact of illegal distribution
and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply
chain; the Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the
effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures
in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s
reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence
on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory
environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property;
exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage
growth, including through potential acquisitions and investments; the risks related to the Company’s acquisitions of or investments in
technologies, products or businesses; the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of
indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the
Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of
terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near
earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities
and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no
obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future
developments occur or otherwise.
Trademarks referenced herein are the property of their respective owners.
©2017 Impax Laboratories, Inc. All Rights Reserved.
3
Impax at a Glance
Generics Division
Targeting high-value solid oral and alternative dosage
form ANDAs that are difficult to develop
• Diversified commercial portfolio of ~72 products
including epinephrine auto-injector, oxymorphone ER
• 23 ANDAs pending approval at FDA including
gRenvela®, gWelchol®, gConverta®, gVytorin®
• 20 ANDAs under development
Specialty Pharma Division
Focused on developing branded Central Nervous
System disorder and other specialty products
• 5 commercialized products including Rytary®, Zomig®
Nasal Spray, Albenza®, Emverm®
• 1 under development - IPX203 next generation Rytary
Pipeline data as of Feb. 24, 2017
A specialty pharmaceutical company applying its formulation expertise and
drug delivery technology to the development, manufacturing and marketing of
specialty branded and generic products
4
Leveraging Our Strengths and Focusing on
Opportunities for Growth
➢ Ensure effective and compliant marketing and sales execution of
specialty products and high-value/difficult-to-formulate generic products
➢ Continue focus on sustainable quality and compliance programs
➢ Select the right products for internal and partnership development
➢ Develop, file and launch on time and capitalize on market opportunities
Leveraging
Our Strengths
➢ Maximize value in Rytary® and invest in IPX203
➢ Improve cost of goods sold and supply chain flexibility
➢ Reduce expenses by identifying additional efficiency opportunities
➢ Increase productivity from internal R&D programs
➢ Diversify via select partnering and business development activities in
both brand and generic businesses
Focusing on
Opportunities
to Drive
Growth
➢ Took steps to reduce costs and improve efficiencies; expected to
produce estimated annual savings between $40MM and $50MM by 2018
➢ Ongoing thorough review of product portfolio and cost structure, which
will provide incremental operational opportunities
Operating
Efficiently
5
Cost Optimization: What We’ve Achieved and 2017 Focus
Completed/In-Process
Estimated Annual Savings
~$40MM-$50MM*
Operational and R&D
restructuring (2015)
Closed central packaging
operation/transferred distribution
to UPS (2015)
Closing Middlesex, NJ
manufacturing and packaging
facility (2017)
Current Initiatives
Confidence in 2017 Cash Flow to
Service Debt & Fund R&D
$50MM voluntary payment
toward term loan late Feb. 2017
Comprehensive portfolio review
and facility utilization analysis
Thoroughly reviewing all cost
functions to identify cost saving
initiatives
*Based on estimates as of Dec. 31, 2016. Currently expect to realize full annual savings beginning in 2018.
Aligning organization and resources to support growth initiatives
and reduce long-term debt
6
Product Therapeutic Area
Parkinson’s Disease
Migraine
Anthelmintic
Anthelmintic
Specialty Pharma Portfolio
7
During 2016…
➢ Completed sales force expansion to 116 reps
➢ Redefined clinical messaging related to formulation and simplified dose conversion
guidance for general neurologists
➢ Launched myRytary Patient Support Program www.myrytary.com
2017 developments…
➢ April 1st, CVS Caremark, moving Rytary on their National Formulary from “Not Covered”
to “Non-Preferred Brand” without edits ~26MM commercial patients
Actions Taken to Deliver Growth
0%
1%
2%
3%
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17
CDLDShare
TRx
Monthly TRx and Share of National CD-LD TRx
Rytary TRx CD-LD Share
(a) Rytary was launched in Feb. 2015.
Source: IMS NPA Monthly Jan. 2017
74% revenue and 114% TRx growth in 2016(a)
8
Specialty Pharma R&D: IPX203 Next Generation Rytary
Investigator Assessment of Motor State
Off Time (h) On Time (h)
Immediate-release CD-LD 7.3 2.7
Rytary 5.5* 4.4*
IPX203 4.6 * + 5.4 * +
* p ≤ 0.0002 compared to IR CD-LD
+ p < 0.05 compared with Rytary
Improvement from Baseline in
MDS-UPDRS Part III
➢ Designed to achieve rapid and sustained levodopa concentration, improved motor
benefits and less frequent dosing
➢ Ongoing Phase 2b multiple dose study in patients with advanced Parkinson’s disease
➢ Phase 2b interim results by end of first half 2017
Positive Phase 2a Study
9
Positive Performance Trend
0%
10%
20%
30%
40%
50%
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Apr-12
Jun-12
Aug-12
Oct-12
Dec-12
Feb-13
Apr-13
Jun-13
Aug-13
Oct-13
Dec-13
Feb-14
Apr-14
Jun-14
Aug-14
Oct-14
Dec-14
Feb-15
Apr-15
Jun-15
Aug-15
Oct-15
Dec-15
Feb-16
Apr-16
Jun-16
Aug-16
Oct-16
Dec-16
NasalTriptanShare
TRx
Monthly TRx and Share of Nasal Triptan TRx Since Assuming Product Promotion
TRx Nasal Triptan Share
➢ Emphasis on second position promotion
➢ Increased non-personal promotion
➢ Solid growth from general neurologists, headache specialists and pediatricians
Source: IMS NPA Monthly Dec 2016; Nasal Segment Imitrex, Sumatriptan, Onzetra Xsail (launched May 2016) and ZOMIG Nasal Spray
9% revenue and 8% TRx growth in 2016
10
0%
10%
20%
30%
40%
50%
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
3/25
4/1
4/8
4/15
4/22
4/29
5/6
5/13
5/20
5/27
6/3
6/10
6/17
6/24
7/1
7/8
7/15
7/22
7/29
8/5
8/12
8/19
8/26
9/2
9/9
9/16
9/23
9/30
10/7
10/14
10/21
10/28
11/4
11/11
11/18
11/25
12/2
12/9
12/16
12/23
12/30
1/6
1/13
1/20
1/27
2/3
2/10
AnthelminticShare
TRx
Weekly TRx and Combined Share of Anthelmintic TRx Since Launch
Albenza TRx Emverm TRx Combined EM and AL Share
➢ Albenza 43% revenue growth in 2016(a)
➢ Emverm launched late 1Q 2016
➢ Focusing on Albenza to Emverm conversion
➢ Increased non-personal promotion of Emverm
Building Awareness of Anthelmintic Franchise
(a) Acquired in the Tower Holdings Acquisition in March 2015.
Source: IMS NPA Monthly Jan. 2017
11
U.S. Generics Overview: A Diversified Portfolio
SOD – Solid Oral Dose; Data as of Feb. 24, 2017
Product Portfolio by Number of
Competing Generic Products
Sole player in market 10%
One 13%
Two 21%
Three 18%
Four or more 38%
62% of Impax’s commercialized portfolio have three or fewer
competing products
Diversified Portfolio of 72
Commercialized Products
▪ 50 immediate-release solid oral
▪ 13 controlled-release solid oral
▪ 9 alternative dosage form
12
➢ Expanded production/supply
➢ Enhanced greater awareness
▪ The “Go To Choice”
▪ Significantly expanded preferred drug list status
▪ CVS agreement
➢ 2016 revenue of $92MM; up 139% over 2015
Generics Business Highlights in 2016
IMS NPA Weekly Feb. 17, 2017
0%
5%
10%
15%
20%
25%
30%
Epinephrine Auto-Injector
Share Growth
Jan. 1, 2016 – Feb. 17, 2017
4%
26%
0%
10%
20%
30%
40%
50%
60%
70%
Oxymorphone ER
Share Growth
Jan. 1, 2016 – Feb. 17, 2017
7.5 & 15 mg 5, 10, 20, 30 & 40 mg
34%
46%
➢ Sole generic player
➢ Captured share of exiting generic player
➢ 2016 revenue of $73MM; up 23% over 2015
48%
58%
Despite Industry challenges, several products in the generic
portfolio delivered strong growth
13
Investing to Expand Pipeline Opportunities
Generic R&D
16
14
7
6
Pending at FDA
$14B
Under Development
$10B
Solid Oral Dose Alternative Dose
23
20
# of Potential
Products
FTF or FTM
8 17
Portfolio of 43 Products
Current U.S. Brand/Generic Market of $24B
Pipeline provides solid platform for growth
Disclosed Pending/TA ANDAs
Greneric Product Name
(BOLD Potential FTM Opportunity)
Brand
IMS
Sales
Oxycodone ER tablet (new formulation) 1 OxyContin® $2.3B
Sevelamer Carbonate IR tablet Renvela® $1.9B
Methylphenidate HCI ER tablet Concerta® $1.8B
Teriflunomide IR tablet Aubagio® $1.1B
Ezetimibe/Simvastatin IR tablet – TA 2 Vytorin® $690M
Colesevelam IR tablet Welchol® $635M
Oxymorphone ER tablet (new formulation) Opana ER® $305M
Fentanyl Buccal IR tablet Fentora® $143M
Dutasteride/Tamsulosin IR capsule Jalyn® $46M
Risedronate Sodium DR tablet Atelvia® $31M
Source of sales data: IMS NPS Dec 2016; Pipeline data as of Feb 24, 2016; TA = tentative approval
1 Launched authorized generic in April 2016
2 Assuming final FDA approval, earliest potential launch date/timing based on settlement or patent
expiration date
FTF – First-to-File; FTM – First-to-Market
14
2017 Priorities
Focus on quality and operations
Effectively execute on Specialty product growth initiatives
Maximize profitability within generic portfolio
Capitalize on new generic product launches
Continue to build diversification within our portfolio
Explore additional expense savings and efficiency opportunities

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Cowen and Company 37th Annual Health Care Conference Presentation

  • 1. 1 Cowen and Company 37th Annual Health Care Conference March 7, 2017
  • 2. 2 Impax Cautionary Statement Regarding Forward Looking Statements "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the impact of competition; the Company’s ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the Company’s lack of a license partner for commercialization of NUMIENTTM (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply chain; the Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions and investments; the risks related to the Company’s acquisitions of or investments in technologies, products or businesses; the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. Trademarks referenced herein are the property of their respective owners. ©2017 Impax Laboratories, Inc. All Rights Reserved.
  • 3. 3 Impax at a Glance Generics Division Targeting high-value solid oral and alternative dosage form ANDAs that are difficult to develop • Diversified commercial portfolio of ~72 products including epinephrine auto-injector, oxymorphone ER • 23 ANDAs pending approval at FDA including gRenvela®, gWelchol®, gConverta®, gVytorin® • 20 ANDAs under development Specialty Pharma Division Focused on developing branded Central Nervous System disorder and other specialty products • 5 commercialized products including Rytary®, Zomig® Nasal Spray, Albenza®, Emverm® • 1 under development - IPX203 next generation Rytary Pipeline data as of Feb. 24, 2017 A specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development, manufacturing and marketing of specialty branded and generic products
  • 4. 4 Leveraging Our Strengths and Focusing on Opportunities for Growth ➢ Ensure effective and compliant marketing and sales execution of specialty products and high-value/difficult-to-formulate generic products ➢ Continue focus on sustainable quality and compliance programs ➢ Select the right products for internal and partnership development ➢ Develop, file and launch on time and capitalize on market opportunities Leveraging Our Strengths ➢ Maximize value in Rytary® and invest in IPX203 ➢ Improve cost of goods sold and supply chain flexibility ➢ Reduce expenses by identifying additional efficiency opportunities ➢ Increase productivity from internal R&D programs ➢ Diversify via select partnering and business development activities in both brand and generic businesses Focusing on Opportunities to Drive Growth ➢ Took steps to reduce costs and improve efficiencies; expected to produce estimated annual savings between $40MM and $50MM by 2018 ➢ Ongoing thorough review of product portfolio and cost structure, which will provide incremental operational opportunities Operating Efficiently
  • 5. 5 Cost Optimization: What We’ve Achieved and 2017 Focus Completed/In-Process Estimated Annual Savings ~$40MM-$50MM* Operational and R&D restructuring (2015) Closed central packaging operation/transferred distribution to UPS (2015) Closing Middlesex, NJ manufacturing and packaging facility (2017) Current Initiatives Confidence in 2017 Cash Flow to Service Debt & Fund R&D $50MM voluntary payment toward term loan late Feb. 2017 Comprehensive portfolio review and facility utilization analysis Thoroughly reviewing all cost functions to identify cost saving initiatives *Based on estimates as of Dec. 31, 2016. Currently expect to realize full annual savings beginning in 2018. Aligning organization and resources to support growth initiatives and reduce long-term debt
  • 6. 6 Product Therapeutic Area Parkinson’s Disease Migraine Anthelmintic Anthelmintic Specialty Pharma Portfolio
  • 7. 7 During 2016… ➢ Completed sales force expansion to 116 reps ➢ Redefined clinical messaging related to formulation and simplified dose conversion guidance for general neurologists ➢ Launched myRytary Patient Support Program www.myrytary.com 2017 developments… ➢ April 1st, CVS Caremark, moving Rytary on their National Formulary from “Not Covered” to “Non-Preferred Brand” without edits ~26MM commercial patients Actions Taken to Deliver Growth 0% 1% 2% 3% 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 CDLDShare TRx Monthly TRx and Share of National CD-LD TRx Rytary TRx CD-LD Share (a) Rytary was launched in Feb. 2015. Source: IMS NPA Monthly Jan. 2017 74% revenue and 114% TRx growth in 2016(a)
  • 8. 8 Specialty Pharma R&D: IPX203 Next Generation Rytary Investigator Assessment of Motor State Off Time (h) On Time (h) Immediate-release CD-LD 7.3 2.7 Rytary 5.5* 4.4* IPX203 4.6 * + 5.4 * + * p ≤ 0.0002 compared to IR CD-LD + p < 0.05 compared with Rytary Improvement from Baseline in MDS-UPDRS Part III ➢ Designed to achieve rapid and sustained levodopa concentration, improved motor benefits and less frequent dosing ➢ Ongoing Phase 2b multiple dose study in patients with advanced Parkinson’s disease ➢ Phase 2b interim results by end of first half 2017 Positive Phase 2a Study
  • 9. 9 Positive Performance Trend 0% 10% 20% 30% 40% 50% 2,000 4,000 6,000 8,000 10,000 12,000 14,000 Apr-12 Jun-12 Aug-12 Oct-12 Dec-12 Feb-13 Apr-13 Jun-13 Aug-13 Oct-13 Dec-13 Feb-14 Apr-14 Jun-14 Aug-14 Oct-14 Dec-14 Feb-15 Apr-15 Jun-15 Aug-15 Oct-15 Dec-15 Feb-16 Apr-16 Jun-16 Aug-16 Oct-16 Dec-16 NasalTriptanShare TRx Monthly TRx and Share of Nasal Triptan TRx Since Assuming Product Promotion TRx Nasal Triptan Share ➢ Emphasis on second position promotion ➢ Increased non-personal promotion ➢ Solid growth from general neurologists, headache specialists and pediatricians Source: IMS NPA Monthly Dec 2016; Nasal Segment Imitrex, Sumatriptan, Onzetra Xsail (launched May 2016) and ZOMIG Nasal Spray 9% revenue and 8% TRx growth in 2016
  • 10. 10 0% 10% 20% 30% 40% 50% 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 3/25 4/1 4/8 4/15 4/22 4/29 5/6 5/13 5/20 5/27 6/3 6/10 6/17 6/24 7/1 7/8 7/15 7/22 7/29 8/5 8/12 8/19 8/26 9/2 9/9 9/16 9/23 9/30 10/7 10/14 10/21 10/28 11/4 11/11 11/18 11/25 12/2 12/9 12/16 12/23 12/30 1/6 1/13 1/20 1/27 2/3 2/10 AnthelminticShare TRx Weekly TRx and Combined Share of Anthelmintic TRx Since Launch Albenza TRx Emverm TRx Combined EM and AL Share ➢ Albenza 43% revenue growth in 2016(a) ➢ Emverm launched late 1Q 2016 ➢ Focusing on Albenza to Emverm conversion ➢ Increased non-personal promotion of Emverm Building Awareness of Anthelmintic Franchise (a) Acquired in the Tower Holdings Acquisition in March 2015. Source: IMS NPA Monthly Jan. 2017
  • 11. 11 U.S. Generics Overview: A Diversified Portfolio SOD – Solid Oral Dose; Data as of Feb. 24, 2017 Product Portfolio by Number of Competing Generic Products Sole player in market 10% One 13% Two 21% Three 18% Four or more 38% 62% of Impax’s commercialized portfolio have three or fewer competing products Diversified Portfolio of 72 Commercialized Products ▪ 50 immediate-release solid oral ▪ 13 controlled-release solid oral ▪ 9 alternative dosage form
  • 12. 12 ➢ Expanded production/supply ➢ Enhanced greater awareness ▪ The “Go To Choice” ▪ Significantly expanded preferred drug list status ▪ CVS agreement ➢ 2016 revenue of $92MM; up 139% over 2015 Generics Business Highlights in 2016 IMS NPA Weekly Feb. 17, 2017 0% 5% 10% 15% 20% 25% 30% Epinephrine Auto-Injector Share Growth Jan. 1, 2016 – Feb. 17, 2017 4% 26% 0% 10% 20% 30% 40% 50% 60% 70% Oxymorphone ER Share Growth Jan. 1, 2016 – Feb. 17, 2017 7.5 & 15 mg 5, 10, 20, 30 & 40 mg 34% 46% ➢ Sole generic player ➢ Captured share of exiting generic player ➢ 2016 revenue of $73MM; up 23% over 2015 48% 58% Despite Industry challenges, several products in the generic portfolio delivered strong growth
  • 13. 13 Investing to Expand Pipeline Opportunities Generic R&D 16 14 7 6 Pending at FDA $14B Under Development $10B Solid Oral Dose Alternative Dose 23 20 # of Potential Products FTF or FTM 8 17 Portfolio of 43 Products Current U.S. Brand/Generic Market of $24B Pipeline provides solid platform for growth Disclosed Pending/TA ANDAs Greneric Product Name (BOLD Potential FTM Opportunity) Brand IMS Sales Oxycodone ER tablet (new formulation) 1 OxyContin® $2.3B Sevelamer Carbonate IR tablet Renvela® $1.9B Methylphenidate HCI ER tablet Concerta® $1.8B Teriflunomide IR tablet Aubagio® $1.1B Ezetimibe/Simvastatin IR tablet – TA 2 Vytorin® $690M Colesevelam IR tablet Welchol® $635M Oxymorphone ER tablet (new formulation) Opana ER® $305M Fentanyl Buccal IR tablet Fentora® $143M Dutasteride/Tamsulosin IR capsule Jalyn® $46M Risedronate Sodium DR tablet Atelvia® $31M Source of sales data: IMS NPS Dec 2016; Pipeline data as of Feb 24, 2016; TA = tentative approval 1 Launched authorized generic in April 2016 2 Assuming final FDA approval, earliest potential launch date/timing based on settlement or patent expiration date FTF – First-to-File; FTM – First-to-Market
  • 14. 14 2017 Priorities Focus on quality and operations Effectively execute on Specialty product growth initiatives Maximize profitability within generic portfolio Capitalize on new generic product launches Continue to build diversification within our portfolio Explore additional expense savings and efficiency opportunities